ClinicalTrials MCP Server

NCT Number,Study Title,Study URL,Acronym,Study Status,Brief Summary,Study Results,Conditions,Interventions,Primary Outcome Measures,Secondary Outcome Measures,Other Outcome Measures,Sponsor,Collaborators,Sex,Age,Phases,Enrollment,Funder Type,Study Type,Study Design,Other IDs,Start Date,Primary Completion Date,Completion Date,First Posted,Results First Posted,Last Update Posted,Locations,Study Documents NCT04534673,Pegylated Interferon Lambda for Treatment of COVID-19 Infection,https://clinicaltrials.gov/study/NCT04534673,,ACTIVE_NOT_RECRUITING,"A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously once weekly, for up to two weeks (2 injections at most), in addition to standard supportive care, compared to standard supportive care alone, in a population of COVID-19 infected patients.patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg S.C + standard care (intervention arm) or standard care only (control arm).",NO,COVID-19,DRUG: Lambda 180 mcg S.C,"Viral shedding in days since initial diagnosis, The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19., 21 days|Rate of adverse events and severe adverse events, Rate of treatment-emergent and treatment-related severe adverse events (SAEs), 21 days from entry","Time to clinical recovery, the time (in hours) from initiation of trial treatment (Lambda or standard care) until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours., 72 Hours|Rate of non-invasive or mechanical ventilation, Requirement for non-invasive (bipap) or mechanical ventilation, 28 Days|Length of hospital stay, length of hospital stay from admission to discharge, 28 Days|All-cause mortality, All-cause mortality, At day 28 following admission to the hospital|Undetectable COVID-19 virus levels, Rate of undetectable COVID-19 virus levels at different days, At days 7,14 and 21 from admission",,Soroka University Medical Center,,ALL,"ADULT, OLDER_ADULT",PHASE2,40,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,0129-20-SOR|SCRC200006,2020-04-07,2023-12-31,2024-12-31,2020-09-01,,2023-05-06,"Soroka UMC, Be'er Sheva, Israel", NCT04445376,Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.,https://clinicaltrials.gov/study/NCT04445376,,COMPLETED,"In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients to measure the improvement.",NO,Covid19,OTHER: Physical Exercises,"6 minute walk test, To measure the cardio-respiratory fitness., 5 weeks|Modified Borg Dyspnea Scale, It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal., 5 weeks","SF-36 QUESTIONNAIRE, The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL, 5 weeks",,Government College University Faisalabad,,ALL,"ADULT, OLDER_ADULT",NA,20,OTHER,INTERVENTIONAL,Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT,313,2020-07-03,2020-09-10,2020-10-03,2020-06-24,,2020-10-08,"Bin Inam Rehabilitation Center., Faisalābad, Punjab, 38000, Pakistan", NCT04292327,Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus,https://clinicaltrials.gov/study/NCT04292327,2019-nCoV,UNKNOWN,"Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.",NO,Pneumonia Caused by Human Coronavirus,,"Mortality, The mortality of COVID-19 in 28 days, 28 day|The time interval of Nucleic acid detection become negative, The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative., 28 day",,,Fujian Provincial Hospital,,ALL,"ADULT, OLDER_ADULT",,400,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,KY-2020-24.01,2020-01-01,2020-04-30,2020-07-31,2020-03-03,,2020-03-03,"Fujian Provincial Hospital, Fuzhou, Fujian, 350000, China", NCT05184127,Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19,https://clinicaltrials.gov/study/NCT05184127,,COMPLETED,"This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of MIR 19® via 14 days of treatment of participants with symptomatic moderate COVID-19.The purpose of this study is to evaluate the efficacy, safety and daily dose of MIR 19 ® for the treatment of the hospitalized patients with infection caused by SARS-CoV-2 (COVID-19) who did not require treatment in the intensive care unit.Based on preclinical data studying antiviral effect of MIR 19® in vitro and in vivo (Khaitov M.R. et all 2021), the investigators hypothesized that SARS-CoV-2 inhibition with MIR 19® could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.",NO,COVID-19,DRUG: MIR 19 ®|COMBINATION_PRODUCT: Standard COVID-19 therapy,"Relief of fever, Reduction in axillary temperature below 37 °C without antipyretic drugs use, Within 14 days|Respiratory rate, Respiratory rate ≤ 22 per minute, Within 14 days|Oxygen saturation, SpO2 \> 94%, Within 14 days|Severity of cough, Severity in a patient's cough no more than 1 point on a four-point scale, Within 14 days",,,National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia,St. Petersburg Research Institute of Vaccines and Sera,ALL,"ADULT, OLDER_ADULT",PHASE2,156,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,SiCoV/KK46- 2021_CSR,2021-04-27,2021-09-07,2021-09-07,2022-01-11,,2022-01-11,"NRC Institute of Immunology FMBA, Moscow, 115478, Russian Federation", NCT04428073,Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection,https://clinicaltrials.gov/study/NCT04428073,,UNKNOWN,GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.,NO,COVID,BIOLOGICAL: Covax-19™,"To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities., Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations., 26 weeks","To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response, Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations., 6 weeks|Virologic response after vaccination, Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4., 4 weeks|Clinical outcome and progression after vaccinations, Number of participants with moderate, severe or critical Covid-19 at week 6., 6 weeks",,GeneCure Biotechnologies,,ALL,ADULT,PHASE1,32,INDUSTRY,INTERVENTIONAL,Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT,GC004,2020-07,2021-07,2021-12,2020-06-11,,2020-06-11,, NCT04686773,"Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention",https://clinicaltrials.gov/study/NCT04686773,,COMPLETED,The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.,NO,COVID-19,BIOLOGICAL: AZD1222|BIOLOGICAL: rAd26-S,"Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination., Antibody seroconversion rate (≥4-fold increase from baseline) to SARS CoV-2 Spike protein 29 days after the second vaccination., Day 57","Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose, Number of Participants Reporting local (Pain at the site of injection, Erythema/hyperemia at the site of injection, Tenderness, Induration/swelling at the site of injection) and systemic (Fever \> 37.8°C, Chills, Muscle pains, Fatigue, Headache, Malaise, Nausea, Vomiting) Solicited Adverse Events for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination)., from Day 1 to Day 8 and From Day 29 to Day 36|Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest, Number of Participants Reporting unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (i.e. up to day 29 after the first vaccination and day 57 after second vaccination)., up to day 29, up to day 57|Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination., The proportion of participants who have a post treatment seroresponse (defined as: ≥ 4 fold rise in titres from Day 1 baseline value) to the SARS CoV-2 Spike protein 29 days post first vaccination., day 29|Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination., The proportion of participants with post treatment seroresponse (defined as: ≥ 4-fold rise in titres from Day 1 baseline value) to receptor-binding domain antigen 29 days post each vaccination., day 29, 57|Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens, Сhange from baseline GMT values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens at day 15, 29, 57, 180., Day 1, 15, 29, 57, 180|Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens, Сhange from baseline GMFR values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens at Day 15, 29, 57, 180., Day 1, 15, 29, 57, 180|Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination, The proportion of participants with post treatment seroresponse (defined as: ≥ 4-fold rise in titres day from Day 1 baseline value to 29 days post each vaccination - Day 29 and Day 57), as measured by SARS-CoV-2 neutralising antibodies, day 29, 57|Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2, Сhange from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2 at Day 15, 29, 57, 180., Day 1, 15, 29, 57, 180|Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2, Сhange from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2 at Day 15, 29, 57, 180., Day 1, 15, 29, 57, 180",,R-Pharm,AstraZeneca|Russian Direct Investment Fund|The Gamaleya National Center of Epidemiology & Microbiology,ALL,"ADULT, OLDER_ADULT",PHASE2,100,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION,CV03872092,2021-03-05,2021-10-30,2022-03-18,2020-12-29,,2022-06-03,"Public legal entity ""Baku Health Center"", Baku, Azerbaijan", NCT05852873,PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway,https://clinicaltrials.gov/study/NCT05852873,PanoramicNOR,RECRUITING,"The goal of this clinical trial is to compare treatment with oral Paxlovid (nirmatrelvir/ritonavir) and placebo for acute COVID-19 as an intervention to prevent long-COVID (post-COVID-19 condition) in adults aged 18-64 years old.The main question it aims to answer is:Does treatment with Paxlovid for acute COVID-19 reduce the prevalence of long-COVID compared to placebo.Participants with acute COVID-19, documented with positive lateral flow test or PCR, within the last 5 days will be randomised to take either Paxlovid or placebo. All participants will receive standard of care in addition. Participants will respond to electronic questionnaires at 14 time points during follow-up. The primary outcome is presence of long-COVID symptoms at 3 months follow-up.Researchers will compare participants who received Paxlovid and placebo to see if Paxlovid treatment can prevent the occurrence of long-COVID.",NO,"Post COVID-19 Condition, Unspecified|SARS-CoV2 Infection|COVID-19",DRUG: Nirmatrelvir/ritonavir|DRUG: Placebo,"Symptoms of long-COVID, a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems)., Change in symptoms from baseline to 3, 6 and 12 months follow-up","Symptoms individually and grouped by organ system, All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neuropsychiatric symptoms)., Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up|Graded responses for symptoms and symptom constellations, Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of the 3 symptoms in the primary outcome., Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up|Risk factors for long-COVID, Analysis of patient characteristics and other factors that may affect the occurrence of long-COVID, Up to 24 months|Severity of acute disease, Severity of acute disease using an 8-step scale (1 - no limitation of activities, 2 - limitations of activities, not hospitalised, 3 - hospitalised not requiring specific treatment, 4 - hospitalised, requiring medical treatment, but not supplemental oxygen, 5 - need of supplemental oxygen, 6 - need of non-invasive ventilatory support (CPAP, BiPAP), 7 - need ov invasive ventilation, 8 - death, 28 days|Hospitalisation, Hospitalisation - binary outcome, 28 days|Severe adverse events, Severe adverse events, Up to 24 months|Absence from work, Absence from work, full or partial sick leave, Up to 24 months|Societal costs, Societal cost / economic analysis, including estimated cost of absence from work/school, hospitalizations, deaths, QALYs lost according to EQ-5D-5L, and more, Up to 24 months|Symptoms of long-COVID, a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems)., Change in symptoms from baseline to 3, 6 and 12 months follow-up",,Haukeland University Hospital,University of Bergen|Oslo University Hospital|University of Oslo|St. Olavs Hospital|Norwegian University of Science and Technology,ALL,ADULT,PHASE3,2000,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION",REC-SE-578741,2023-05-12,2024-04,2026-04,2023-05-10,,2023-10-18,"Haukeland University Hospital, Bergen, Vestland, 5021, Norway","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT05852873/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT05852873/SAP_002.pdf" NCT04498273,COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80,https://clinicaltrials.gov/study/NCT04498273,,TERMINATED,A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis,YES,COVID-19,DRUG: Apixaban 2.5 MG|DRUG: Apixaban 5MG|DRUG: Aspirin|DRUG: Placebo,"Hospitalization for Cardiovascular/Pulmonary Events, The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment., 45 days",,,Frank C Sciurba,"National Heart, Lung, and Blood Institute (NHLBI)",ALL,"ADULT, OLDER_ADULT",PHASE3,657,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION",ACTIV4-Outpatient,2020-09-07,2021-08-05,2021-08-05,2020-08-04,2022-02-17,2022-02-17,"University of Southern California, Los Angeles, California, 90033, United States|Stanford University School of Medicine, Palo Alto, California, 94304, United States|Zuckerberg San Francisco General, San Francisco, California, 94143, United States|Olive View-UCLA Medical Center, Sylmar, California, 91342, United States|Pine Ridge Family Medicine, Colorado Springs, Colorado, 80924, United States|Life Tree Health, Inc., Washington, District of Columbia, 20020, United States|Midland Florida Clinical Research Center, LLC, DeLand, Florida, 23720, United States|University of Florida at Gainesville, Gainesville, Florida, 32611, United States|Vital Pharma Research, Hialeah, Florida, 33016, United States|Advanced Research for Health Improvement, LLC, Immokalee, Florida, 34142, United States|University of Floridia at Jacksonville, Jacksonville, Florida, 32209, United States|Lakeland Regional, Lakeland, Florida, 33805, United States|Total Research Group LLC, Miami, Florida, 33126, United States|Jackson Memorial, Miami, Florida, 33136, United States|Well Pharma Medical Research, Miami, Florida, 33173, United States|Innovation Clinical Trials, Palmetto Bay, Florida, 33157, United States|Bond Community Health Center, Tallahassee, Florida, 32301, United States|Tallahassee Memorial, Tallahassee, Florida, 32308, United States|USF Tampa General Hospital, Tampa, Florida, 33606, United States|Alliance Clinical Research, Tampa, Florida, 33615, United States|Hawaii Pacific Health, Honolulu, Hawaii, 96813, United States|Fox Valley Clinical Research Center, LLC, Aurora, Illinois, 60506, United States|UIC - Mile Square, Chicago, Illinois, 60608, United States|Jesse Brown VA, Chicago, Illinois, 60612, United States|University of Illinois at Chicago, Chicago, Illinois, 60612, United States|Olivo Wellness Medical Center, Chicago, Illinois, 60618, United States|University of Chicago, Chicago, Illinois, 60637, United States|OSF Saint Francis Medical Center, Peoria, Illinois, 61637, United States|Ascension Via Christi, Wichita, Kansas, 67214, United States|University Medical Center New Orleans, New Orleans, Louisiana, 70112, United States|Jadestone Clinical Research, LLC, Gaithersburg, Maryland, 20877, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States|GFC of Southeastern Michigan, Detroit, Michigan, 48202, United States|SRI International, Plymouth, Michigan, 48170, United States|Metro Health-University of Michigan Health, Wyoming, Michigan, 49519, United States|Raritan Bay Primary Care and Cardiology Associates, Matawan, New Jersey, 07747, United States|G&S Medical Associates, LLC, Paterson, New Jersey, 07514, United States|University of New Mexico, Albuquerque, New Mexico, 87131, United States|Montefiore Medical Center, Bronx, New York, 10467, United States|Strong Memorial, Rochester, New York, 14642, United States|Spinal Pain and Rehab Medicine, Yonkers, New York, 10701, United States|Duke, Durham, North Carolina, 27701, United States|Peters Medical Research, High Point, North Carolina, 27262, United States|The Heart and Medical Center, Durant, Oklahoma, 74701, United States|Ascension St. John Clinical Research Institute, Tulsa, Oklahoma, 74104, United States|UPMC Passavant Cranberry, Cranberry, Pennsylvania, 16066, United States|UPMC McKeesport, McKeesport, Pennsylvania, 15132, United States|UPMC East, Monroeville, Pennsylvania, 15146, United States|UPMC Magee, Pittsburgh, Pennsylvania, 15213, United States|UPMC Presby, Pittsburgh, Pennsylvania, 15213, United States|UPMC Mercy, Pittsburgh, Pennsylvania, 15219, United States|Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, 15220, United States|UPMC Shadyside, Pittsburgh, Pennsylvania, 15232, United States|UPMC Passavant McCandless, Pittsburgh, Pennsylvania, 15237, United States|Preferred Primary Care Physicians, Inc, Pittsburgh, Pennsylvania, 15243, United States|Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, 15243, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Pharma Tex Research, Amarillo, Texas, 79109, United States|Ascension Seton Medical Center, Austin, Texas, 78752, United States|Baptist Beaumont, Beaumont, Texas, 77030, United States|McGoven Medical School - UT- Houston, Houston, Texas, 77030, United States|Diversifield Medical Practices, Houston, Texas, 77057, United States|Next Level Urgent Care, Houston, Texas, 77057, United States|Mesquite Regional Internal Medicine, Mesquite, Texas, 75149, United States|University of Texas at Tyler, Tyler, Texas, 75708, United States|University of Texas at Rio Grande Valley, Weslaco, Texas, 78596, United States|Intermountain Healthcare, Murray, Utah, 84107, United States|Community Care of Clay, Clay, West Virginia, 25043, United States|University Healthcare Physicians, Harpers Ferry, West Virginia, 25425, United States|Community Care of Weston, Weston, West Virginia, 26452, United States|Gundersen Health System, La Crosse, Wisconsin, 54601, United States","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT04498273/Prot_001.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT04498273/SAP_002.pdf" NCT04392973,FAvipiravir and HydroxyChloroquine Combination Therapy,https://clinicaltrials.gov/study/NCT04392973,FACCT,COMPLETED,"This study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care.",NO,COVID19,COMBINATION_PRODUCT: Favipiravir and Hydroxychloroquine,"Clinical Improvement, The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first., 28 days","Viral shedding, PCR test negative conversion days from positive to negative., 28 days",,King Abdullah International Medical Research Center,,ALL,"ADULT, OLDER_ADULT",NA,268,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,RC20/174,2020-05-21,2021-01-26,2021-04-26,2020-05-19,,2021-08-20,"King Abdulaziz Hospital - Al Ahsa, Hasa, Eastern Region, Saudi Arabia|AlMadina General Hospital, Al Madīnah, Saudi Arabia|Al-Qatif Central Hospital, Al-Qatif, Saudi Arabia|Imam Abdulrahman Al Faisal Hospital - Dammam, Dammam, Saudi Arabia|King Abdulaziz Medical City, Jeddah, Saudi Arabia|King Abdulaziz Hospital - Makkah, Mecca, Saudi Arabia|King Abdulaziz Medical City, National Guard Health Affairs, Riyadh, 11426, Saudi Arabia|Imam Abdulrahman Alfaisal Hospital, Riyadh, Saudi Arabia", NCT05813873,The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome,https://clinicaltrials.gov/study/NCT05813873,,RECRUITING,"The aim of this clinical trial is to investigate the efficacy of Triflow in the rehabilitation of patients with long covid syndrome hospitalised in a rehabilitation center. Participants will be divided into 2 groups and follow their exercise regime until the day they are discharged from the rehabilitation center. The intervention group will participate in a rehabilitation program which includes upper and lower limbs exercises, cycle ergometer, walking and the use of triflow. The control group will participate in the same program but without the Triflow.",NO,Long COVID,OTHER: Triflow|OTHER: Control,"Barthel Index, Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living., on admission day|Barthel Index, Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living., on discharge day|Dyspnoea (Medical Research Council Dyspnoea Scale), Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is, on admission day|Dyspnoea (Medical Research Council Dyspnoea Scale), Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is, on discharge day|Peak Flow Meter, Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is, on admission day|Peak Flow Meter, Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is, on discharge day","Number of hospitalisation days, Number of days participants stay in the rehabilitation center, on discharge day|Muscle strength (Hand Grip), Assess muscle strength for the upper extremities via hand-held dynamometer, on admission day|Muscle strength (Hand Grip), Assess muscle strength for the upper extremities via hand-held dynamometer, on discharge day|Muscle strength and endurance (30 seconds Sit to stand), Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance, on admission day|Muscle strength and endurance (30 seconds Sit to stand), Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance, on discharge day|Balance (Berg Balance), Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls., on admission day|Balance (Berg Balance), Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls., on discharge day|Cardiorespiratory fitness (Six minutes walking test), Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness., on admission day|Cardiorespiratory fitness (Six minutes walking test), Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness., on discharge day|Quality of life (EQ-5D-5L), Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health), on admission day|Quality of life (EQ-5D-5L), Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health), on discharge day|Fatigue (Multidimensional fatigue inventory), Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true), on admission day|Fatigue (Multidimensional fatigue inventory), Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true), on discharge day|Timed up and Go, Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility, on admission day|Timed up and Go, Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility, on discharge day",,European University Cyprus,Eden Resort Wellness Rehabilitation Center,ALL,"ADULT, OLDER_ADULT",NA,70,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT,Triflow,2022-12-21,2024-12-23,2025-12-31,2023-04-14,,2024-02-20,"Eden Resort Wellness Rehabilitation Center, Larnaca, 7562, Cyprus", NCT06097273,"A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age",https://clinicaltrials.gov/study/NCT06097273,,COMPLETED,"The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).",NO,SARS-CoV-2|Influenza,BIOLOGICAL: mRNA-1083|BIOLOGICAL: Placebo|BIOLOGICAL: Influenza Vaccine|BIOLOGICAL: COVID-19 Vaccine,"Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay, Day 29|GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA), Day 29|Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay, Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay., Baseline to Day 29|SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA, Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\*LLOQ if baseline titer is \<LLOQ in neutralizing antibody (nAb) values measured by PsVNA., Baseline to Day 29|Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs), Up to 7 days after study injection|Number of Participants With Unsolicited Adverse Events (AEs), Up to 28 days after study injection|Number of Participants With Medically Attended Adverse Events (MAAEs), Day 1 through Day 181|Number of Participants With Adverse Events of Special Interest (AESIs), Day 1 through Day 181|Number of Participants With Serious Adverse Events (SAEs), Day 1 through Day 181|Number of Participants With AEs Leading to Discontinuation, Day 1 through Day 181","Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay, Day 1, Day 29|GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA, Day 1, Day 29|GM Level of Antibodies for Influenza, as Measured by Microneutralization Assay, Day 29|GMFR of Antibodies for Influenza, as Measured by Microneutralization Assay, Day 1, Day 29",,"ModernaTX, Inc.",,ALL,"ADULT, OLDER_ADULT",PHASE3,8075,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION",mRNA-1083-P301,2023-10-19,2024-05-28,2024-05-28,2023-10-24,,2024-06-24,"Pinnacle Research Group-409 E 10th St, Anniston, Alabama, 36207-4780, United States|Accel Research Site - Achieve - Birmingham, Birmingham, Alabama, 35216, United States|Cullman Clinical Trials, Cullman, Alabama, 35055-1902, United States|Desert Clinical Research - CCT - PPDS, Mesa, Arizona, 85213-5226, United States|Foothills Research Center - CCT - PPDS, Phoenix, Arizona, 85044-6097, United States|Headlands Research - Scottsdale - PPDS, Scottsdale, Arizona, 85260-6411, United States|Scottsdale Clinical Trials, Scottsdale, Arizona, 85260-6742, United States|Fiel Family & Sports Medicine - PC - CCT - PPDS, Tempe, Arizona, 85283-1528, United States|AES - DRS - Synexus Clinical Research US, Inc. - Cerritos, Cerritos, California, 90703-2544, United States|Long Beach Research Institute, LLC, Long Beach, California, 90805-4587, United States|CenExel Apex (CNS) - Los Alamitos - PPDS, Los Alamitos, California, 90720-3118, United States|Central Valley Research, LLC, Modesto, California, 95350-5365, United States|Carbon Health- NoHo West Urgent Care and Primary Care, North Hollywood, California, 91606-3287, United States|Empire Clinical Research, Pomona, California, 91767-1800, United States|Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS, Riverside, California, 92503-4955, United States|Clinical Innovations Trials - Riverside - CenExel - PPDS, Riverside, California, 92506-3257, United States|Peninsula Research Associates - Headlands - PPDS, Rolling Hills Estates, California, 90274-7604, United States|Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS, San Diego, California, 92103-2204, United States|AES - DRS - Synexus Clinical Research US, Inc. - Vista, Vista, California, 92083-6051, United States|Tekton Research - Fort Collins - PPDS, Fort Collins, Colorado, 80525-5752, United States|Tekton Research - Longmont - PPDS, Longmont, Colorado, 80501-6461, United States|Stamford Therapeutics Consortium - ERN - PPDS, Stamford, Connecticut, 06905-5316, United States|Chase Medical Research LLC - Waterbury, Waterbury, Connecticut, 06708-3346, United States|Revival Research Corporation, Doral, Florida, 33122-1902, United States|Indago Research and Health Center, Hialeah, Florida, 33012, United States|CenExel RCA - Hollywood, Hollywood, Florida, 33024-2709, United States|Nature Coast Clinical Research, Inverness, Florida, 34452, United States|Jacksonville Center For Clinical Research, Jacksonville, Florida, 32216, United States|Health Awareness - Jupiter - ERN - ERN, Jupiter, Florida, 33458-2775, United States|Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS, Largo, Florida, 33777-1359, United States|Flourish Research - Leesburg - PPDS, Leesburg, Florida, 34748-5077, United States|Accel Research Sites - Maitland, Maitland, Florida, 32751-7258, United States|AES - DRS - Optimal Research Florida - Melbourne, Melbourne, Florida, 32934-8172, United States|Suncoast Research Group LLC - Flourish - PPDS, Miami, Florida, 33135-1687, United States|St. Johns Center for Clinical Research - ERN - PPDS, Saint Augustine, Florida, 32086-5775, United States|ForCare Clinical Research - CenExel FCR - PPDS, Tampa, Florida, 33613-1244, United States|AES - DRS - Synexus Clinical Research US, Inc. - Atlanta, Atlanta, Georgia, 30328-4018, United States|DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS, Atlanta, Georgia, 30329-2201, United States|iResearch Atlanta - CenExel - PPDS, Decatur, Georgia, 30030-3438, United States|Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS, Fayetteville, Georgia, 30214, United States|Georgia Clinic - CCT - PPDS, Norcross, Georgia, 30092-4544, United States|Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS, Savannah, Georgia, 31406-3928, United States|Clinical Research Atlanta - ERN - PPDS, Stockbridge, Georgia, 30281-9054, United States|AES - DRS - Synexus Clinical Research US, Inc. - Chicago, Chicago, Illinois, 60602-3960, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607-4559, United States|Flourish Research - Andersonville - PPDS, Chicago, Illinois, 60640-2781, United States|Koch Family Medicine, Morton, Illinois, 61550-2495, United States|AES - DRS - Optimal Research Illinois - Peoria, Peoria, Illinois, 61614, United States|DM Clinical Research - Chicago - ERN - PPDS, River Forest, Illinois, 60305-1876, United States|AES - DRS - Synexus Clinical Research US, Inc. - Evansville, Evansville, Indiana, 47714-7513, United States|Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS, Valparaiso, Indiana, 46383-2195, United States|The Iowa Clinic, P.C. - West Des Moines Campus, West Des Moines, Iowa, 50266-8216, United States|Johnson County Clin-Trials, Lenexa, Kansas, 66219-1389, United States|Delricht Overland Park, Overland Park, Kansas, 66223-4857, United States|Tekton Research - Wichita - PPDS, Wichita, Kansas, 67218-2913, United States|DelRicht Research, LLC - Louisville - PPDS, Louisville, Kentucky, 40205-3162, United States|Versailles Family Medicine - CCT - PPDS, Versailles, Kentucky, 40383-1947, United States|Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS, Baton Rouge, Louisiana, 70809-3416, United States|Velocity Clinical Research - Covington - PPDS, Covington, Louisiana, 70433-7237, United States|DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS, Mandeville, Louisiana, 70471, United States|IMA Clinical Research - Monroe, LA - PPDS, Monroe, Louisiana, 71201-3915, United States|DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS, New Orleans, Louisiana, 70115-3584, United States|DelRicht Research, LLC - Internal - Baton Rouge - PPDS, Prairieville, Louisiana, 70769-4222, United States|Annapolis Internal Medicine - CCT - PPDS, Annapolis, Maryland, 21401-7050, United States|Advanced Primary Care & Geriatric Care - CCT - PPDS, Rockville, Maryland, 20850-6246, United States|DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS, Rockville, Maryland, 20852-3803, United States|Velocity Clinical Research (Rockville - Maryland) - PPDS, Rockville, Maryland, 20854-2960, United States|Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS, Silver Spring, Maryland, 20901-4402, United States|DM Clinical Research - The Brook House - ERN - PPDS, Brookline, Massachusetts, 02445-7113, United States|Headlands Research - Detroit - Headlands - PPDS, Southfield, Michigan, 48034-1088, United States|Great Lakes Research Institute, Southfield, Michigan, 48075-5400, United States|DM Clinical Research - Southfield - ERN - PPDS, Southfield, Michigan, 48076-5412, United States|Mankato Clinic - Premier Drive - Javara - PPDS, Mankato, Minnesota, 56001-6076, United States|AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis, Richfield, Minnesota, 55423-2590, United States|DelRicht Research, LLC - Gulfport - PPDS, Gulfport, Mississippi, 39503-4176, United States|AES - DRS - Synexus Clinical Research US, Inc. - St. Louis, Creve Coeur, Missouri, 63141-7084, United States|Clay Platte Family Medicine - CCT Research, Kansas City, Missouri, 64151-2411, United States|Sundance Clinical Research - ERN - PPDS, Saint Louis, Missouri, 63141-7068, United States|Clinvest - National Ave - Headlands - PPDS, Springfield, Missouri, 65807-6012, United States|DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS, Springfield, Missouri, 65807-7303, United States|DelRicht Clinical Research, LLC - MS. Medicine - PPDS, Town And Country, Missouri, 63017-8209, United States|Skyline Medical Center - PC - CCT - PPDS, Elkhorn, Nebraska, 68022-2889, United States|Methodist Physicians Clinic - CCT Research - PPDS, Fremont, Nebraska, 68025-2592, United States|Velocity Clinical Research (Lincoln - Nebraska) - PPDS, Lincoln, Nebraska, 68510-4855, United States|Velocity Clinical Research, Omaha, Nebraska, 68134, United States|Midwest Regional Health Services - LLC - CCT - PPDS, Omaha, Nebraska, 68144, United States|Papillion Research Center, Papillion, Nebraska, 68046-4194, United States|AES - DRS - Synexus Clinical Research US, Inc. - Henderson, Henderson, Nevada, 89052-3992, United States|Santa Rosa Urgent Care - Primary Care - CCT - PPDS, Las Vegas, Nevada, 89119-5483, United States|Las Vegas Clinical Trials, North Las Vegas, Nevada, 89030-7187, United States|Hassman Research Institute - HRI - Berlin - CenExel - PPDS, Berlin, New Jersey, 08009, United States|Velocity Clinical Research - Albuquerque - PPDS, Albuquerque, New Mexico, 87107-4503, United States|AXCES Research Group - Sante Fe - ERN - PPDS, Santa Fe, New Mexico, 87505-4753, United States|DM Clinical Research - Brooklyn, Brooklyn, New York, 11220-5906, United States|AES - DRS - Synexus Clinical Research US, Inc. - New York, New York, New York, 10017-4008, United States|Rochester Clinical Research, Inc, Rochester, New York, 14609-3173, United States|DelRicht Research, LLC - Charlotte - PPDS, Charlotte, North Carolina, 28205-5078, United States|Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS, Charlotte, North Carolina, 28287-3884, United States|Monroe Biomedical Research -343 Venus St, Monroe, North Carolina, 28112-4025, United States|Trial Management Associates LLC - ERN - PPDS, Wilmington, North Carolina, 28403-6235, United States|CTI Clinical Research Center - PPDS, Cincinnati, Ohio, 45212, United States|Velocity Clinical Research (Cincinnati - Ohio) - PPDS, Cincinnati, Ohio, 45219-2975, United States|AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati, Cincinnati, Ohio, 45236-3669, United States|Velocity Clinical Research (Cincinnati - Ohio) - PPDS, Cincinnati, Ohio, 45246-2316, United States|AES - DRS - Synexus Clinical Research US, Inc. - Columbus, Columbus, Ohio, 43212-3119, United States|WellNow Urgent Care & Research - Huber Heights, Huber Heights, Ohio, 45424-4019, United States|Tekton Research - Edmond - PPDS, Edmond, Oklahoma, 73013-5478, United States|Lynn Institute of East Oklahoma - ERN - PPDS, Oklahoma City, Oklahoma, 73111-3324, United States|DelRicht Research, LLC - Internal - Tulsa - PPDS, Tulsa, Oklahoma, 74133-8902, United States|Tekton Research - Yukon - PPDS, Yukon, Oklahoma, 73099-9518, United States|The Corvallis Clinic, PC - 3680 NW Samaritan Drive, Corvallis, Oregon, 97330-3737, United States|Hatboro Medical Associates - CCT - PPDS, Hatboro, Pennsylvania, 19040-2045, United States|DM Clinical Research - Philadelphia - ERN - PPDS, Philadelphia, Pennsylvania, 19107-1530, United States|AES - DRS - Synexus Clinical Research US, Inc. - Anderson, Anderson, South Carolina, 29621-2062, United States|TMA - Myrtle Beach - ERN - PPDS, Myrtle Beach, South Carolina, 29572-4610, United States|Velocity Clinical Research - Spartanburg - PPDS, Spartanburg, South Carolina, 29303-4225, United States|DelRicht Research, LLC - Hendersonville - PPDS, Hendersonville, Tennessee, 37075-8947, United States|AES - DRS - Optimal Research Texas - Austin, Austin, Texas, 78705-2655, United States|Benchmark Research - Austin - HyperCore - PPDS, Austin, Texas, 78705-3298, United States|Tekton Research - Austin - PPDS, Austin, Texas, 78745, United States|Tekton Research Inc, Beaumont, Texas, 77706-3061, United States|Headlands Research - Brownsville - Headlands - PPDS, Brownsville, Texas, 78526-4332, United States|AES - DRS - Synexus Clinical Research US, Inc. - Dallas, Dallas, Texas, 75234-7858, United States|3A Research, LLC, El Paso, Texas, 79925, United States|Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS, Fort Worth, Texas, 76133-4953, United States|Mount Olympus Medical Research Group - ClinEdge - PPDS, Friendswood, Texas, 77546, United States|DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS, Houston, Texas, 77065-5685, United States|DM Clinical Research - Bellaire - ERN - PPDS, Houston, Texas, 77081-4648, United States|DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS, Humble, Texas, 77338-4205, United States|DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS, McKinney, Texas, 75070-8481, United States|Benchmark Research - San Angelo - HyperCore - PPDS, San Angelo, Texas, 76904-7610, United States|Sun Research Institute -427 9th St, San Antonio, Texas, 78215-1528, United States|Clinical Trials of Texas, Inc. - PPDS, San Antonio, Texas, 78229-3539, United States|IMA Clinical Research - San Antonio - PPDS, San Antonio, Texas, 78229, United States|Tekton Research - San Antonio - PPDS, San Antonio, Texas, 78229, United States|Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS, San Marcos, Texas, 78666-9734, United States|Privia Medical Group- North Texas - Stephenville - Javara - PPDS, Stephenville, Texas, 76401-1860, United States|DM Clinical Research - Sugarland - ERN - PPDS, Sugar Land, Texas, 77478-4913, United States|DM Clinical Research - ERN - PPDS, Tomball, Texas, 77375-3330, United States|Cope Family Medicine - CCT - PPDS, Bountiful, Utah, 84010-4862, United States|Ogden Clinic - Mountain View - CCT - PPDS, Pleasant View, Utah, 84404-4791, United States|Ogden Clinic - Grandview - CCT - PPDS, Roy, Utah, 84067-9438, United States|AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City, S. Salt Lake, Utah, 84106-1466, United States|JBR Clinical Research - CenExel JBR - PPDS, Salt Lake City, Utah, 84107-4536, United States|Velocity Clinical Research - Family Practice - Portsmouth - PPDS, Portsmouth, Virginia, 23703-3200, United States|Wenatchee Valley Hospital & Clinics Campus, Wenatchee, Washington, 98801-2028, United States", NCT05532995,Responses to CPET in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network,https://clinicaltrials.gov/study/NCT05532995,,COMPLETED,"This retrospective collaborative study on persistent exercise intolerance after COVID-19 offers to perform a large descriptive analysis of CPET performed in real-life by pulmonologists, cardiologists and physiologists. Indeed, these practicians are regularly consulted for a persistent intolerance to exercise expressed by dyspnea and/or frank fatigability sometimes associated with muscular or thoracic pain. When these complaints persist beyond 3 months after the first symptoms, it is legitimate to perform a CPET:* Either to evaluate the functional impact of an identified organ deficiency (e.g. myocarditis, pulmonary fibrosis, etc.),* Or, in the absence of formal arguments for an identified organ deficiency, to observe possible abnormalities in physiological responses during an incremental exercise test, likely to explain the persistence of symptoms and intolerance to exercise. Indeed, the recent literature highlights the presence of non-specific ventilatory and cardio-circulatory abnormalities leading to various physio-pathological observations. Unfortunately, these reports now concern relatively small numbers of patients with very diverse clinical forms of Covid, comorbidities and habitus.In order to improve the understanding of persistent symptoms and in particular the diversity of physiological response presentations, the investigators propose to collect a very large amount of data through a web-based platform designed to collect the measurements made throughout the exercise test directly from the ergospirometer.The relevant data covers the period from January 2, 2020 to December 31, 2022 (i.e. 35 months), The retrospective data collection will be carried out from February 1, 2023 to December 31, 2023.The descriptive analysis will focus on the kinetics of all the variables measured and calculated on subgroups defined a priori on age, sex, comorbidities, acute covid severity, persistent symptoms post covid, regular habitual physical activity level, etc. according to the sample.The study is expected to collect data from around 1000 patients and to involve around 40 French-speaking investigators. However, this collaborative study is open on request to all centers wishing to participate, as the web platform has been developed for data collection in English.",NO,COVID-19,,"An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder, A descriptive analysis of all evaluation criteria will be performed on the total population and on subgroups to be defined a posteriori according to the sample (December 2023).",,,Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie,"Menarini Group|Hylab, Grenoble|AstraZeneca",ALL,"ADULT, OLDER_ADULT",,1200,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,ACCPP-PROT2022-01,2022-07-15,2023-12-31,2023-12-31,2022-09-08,,2024-05-21,"Hosp. Maisonneuve-Rosemont, Montréal, Canada|University Hosp. Amiens-Picardie, Amiens, France|Angers University Hosp., Angers, France|AP-HP University Hosp. Avicenne, Bobigny, France|Brest University Hosp. Cavale Blanche, Brest, France|Hosp. Louis Pradel, Bron, France|SSR Marguerite Boucicaut French Red Cross, Chalon-sur-Saône, France|University Hosp. Gabriel-Montpied, Clermont-Ferrand, France|Corbie General Hosp. (Réadaptation), Corbie, France|Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé, Dieulefit, France|Centre Médical Bayère, Gleizé, France|Grenoble Alpes University Hosp. Michallon Nord, Grenoble, France|Grenoble Alpes University Hosp. Michallon Sud, Grenoble, France|Hosp. St Philibert GH Catholique Institute Lille, Lille, France|Limoges General Hosp., Limoges, France|Medical Center Parot, Lyon, France|Médipôle Lyon-Villeurbanne, Lyon, France|Nice University Hosp. Pasteur, Nice, France|Clinique Les Rieux, Nyons, France|AP-HP Hôpital Bichat Claude-Bernard, Paris, France|AP-HP University Hosp. Cochin, Paris, France|AP-HP University Hosp. Pitié Salpêtrière, Paris, France|Polyclinique Les Bleuets, Reims, France|University Hosp. of Pontchaillou, Rennes, France|Rouen University Hosp. Charles-Nicolle, Rouen, France|Toulouse University Hosp., Toulouse, France|Tours University Hosp. Bretonneau, Tours, France|Clinique Saint Paul, Fort-de-France, Martinique|Geneva University Hosp., Geneva, Switzerland","Study Protocol and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/95/NCT05532995/Prot_ICF_001.pdf" NCT04388514,Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure,https://clinicaltrials.gov/study/NCT04388514,CORMOR,UNKNOWN,"Aim. The emerging outbreak of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Beside the prescription of some promising drugs as chloroquine, azithromycin, antivirals (lopinavir/ritonavir, darunavir/cobicistat) and immunomodulating agents (steroids, tocilizumab), in our patients with mild to moderate pneumonia due to SARS-CoV-2 we planned a randomize study to evaluate, respect the best available therapy (BAT), the use of autohemotherapy treatement with an oxygen/ozone (O3) gaseous mixture as adjuvant therapy.Design. Multicentric, randomized study.Participants. Clinical presentations are based upon clinical phenotypes identified by the Italian Society of Emergency and Urgency Medicine (SIMEU - Società Italiana di Medicina di Emergenza-Urgenza) and patients that meet criteria of phenotypes 2 to 4 were treat with best available therapy (BAT), and randomized to receive or not O3-autohemotherapy.Main outcome measures. The end-point were the time of respiratory improvement and earlier weaning from oxygen support: these parameters were included in the SIMEU clinical phenotypes classification.",NO,SARS-CoV-2 Respiratory Failure,PROCEDURE: Medical Ozone procedure,"Time of respiratory improvement and earlier weaning from oxygen support, Evaluation of ABG paramethers the day after the last blood ozonization procedure (Day 3), 3 days|The time of respiratory improvement and earlier weaning from oxygen support, Evaluation of ABG paramethers the one week after the last blood ozonization procedure (Day 10), 10 days","Assessment of the length of hospitalization, Asse the lenghth of hospital stay in the two arms, up to 90 days|Assessment of the length of Intensive Care Unit (ICU) stay, Asse the lenghth of ICU stay in the two arms, up to 90 days|Improvment in chest imaging finding, improving, worsening or stability of the chest imaging (chest CT, Chest XR and/or Point-of-Care Ultrasound) finding in the two arms, 10 days|Improvment in cytokine release syndrome, Evaluation of plasmatic cytochine (IL-6, lymphocyte typing for CD4, CD3, CD8, HLA-DR, CD45) response in the two arms, 10 days",,Azienda Sanitaria-Universitaria Integrata di Udine,"Fondazione Toscana Gabriele Monasterio|Policlinico Militare, Roma - Italy|Ospedale San Liberatore di Atri|Ospedale Umberto I di Torino|Università di Siena|Ospedale Civile di Lucca|Ospedale di Siracusa|Azienda Sanitaria Locale di Vercelli",ALL,"ADULT, OLDER_ADULT",NA,90,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT,CIG: Z7C2CA5837,2020-04-08,2020-10-08,2020-10-08,2020-05-14,,2020-05-14,"Dott. Amato De Monte, Udine, Italy","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/14/NCT04388514/Prot_SAP_000.pdf" NCT04329195,ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic,https://clinicaltrials.gov/study/NCT04329195,ACORES-2,TERMINATED,"Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19.Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19.It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.",NO,History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection,DRUG: 1: discontinuation of RAS blocker therapy|DRUG: 2: continuation of RAS blocker therapy,"Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first), Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first), from day 0 to day 28 or hospital discharge","Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28, Major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28, at day 28|Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28., Clinical status as assessed with the seven-category ordinal scale. The seven-category ordinal scale consisted of the following categories:1. not hospitalized with resumption of normal activities2. not hospitalized, but unable to resume normal activities3. hospitalized, not requiring supplemental oxygen4. hospitalized, requiring supplemental oxygen5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both7. death., at days 7, 14 and 28|Number of days alive free of oxygen., Number of days alive free of oxygen., from day 0 to day 28 or hospital discharge|Number of days alive outside hospital until day28, Number of days alive outside hospital, at day28|Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28, Ventilation (invasive or non-invasive), at day28|Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28, Number of days alive free of mechanical ventilation (invasive or non-invasive), at day28|Number of days alive free of ICU admission until day28, Number of days alive free of ICU admission, at day28|Rate of all-cause mortality at day 28, Rate of all-cause mortality, at day 28|Rate of cardiovascular death at day 28, Rate of cardiovascular death, at day 28|Number of days alive free of acute kidney injury until hospital discharge, Number of days alive free of acute kidney injury, at day 28 to hospital discharge",,Assistance Publique - Hôpitaux de Paris,Groupe Hospitalier Pitié-Salpêtrière,ALL,"ADULT, OLDER_ADULT",PHASE3,44,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,APHP200409,2020-04-09,2020-12-09,2021-01-09,2020-04-01,,2021-04-09,"Cardiologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, 75013, France", NCT04517695,Blood Volume Assessment in COVID-19 and Bacterial Sepsis,https://clinicaltrials.gov/study/NCT04517695,BVAC19,COMPLETED,"In patients with SARS-CoV-2 or bacterial infection admitted to the intensive care unit (ICU), the state of the intravascular volume, the characteristics of the blood volume components, and the development of a vascular leak is currently unknown. The relationship of these parameters with parameters of cardiac performance, lung edema and sublingual microcirculatory perfusion parameters have never been studied.",NO,Covid19|Acute Respiratory Distress Syndrome|Bacterial Sepsis|Bacterial Infections,DEVICE: BVA-100|DEVICE: Transpulmonary Thermodilution (TPTD)|DEVICE: Sublingual Microcirculation,"Change in Absolute Total Blood Volume, Absolute total blood volume calculated using BVA-100 software., Day 1, Day of ICU Discharge (up to day 21)|Change in Total Blood Volume Relative to Ideal Body Weight, Total blood volume relative to ideal body weight calculated using the BVA-100 software., Day 1, Day of ICU Discharge (up to day 21)|Change in Absolute Red Blood Cell Volume, Absolute red blood cell volume calculated using the BVA-100 software., Day 1, Day of ICU Discharge (up to day 21)|Change in Red Blood Cell Volume Relative to Ideal Body Weight, Red blood cell volume relative to ideal body weight calculated using the BVA-100 software., Day 1, Day of ICU Discharge (up to day 21)|Change in Absolute Plasma Volume, Absolute plasma volume calculated using the BVA-100 software., Day 1, Day of ICU Discharge (up to day 21)|Change in Plasma Volume Relative to Ideal Body Weight, Plasma volume relative to ideal body weight calculated using the BVA-100 software., Day 1, Day of ICU Discharge (up to day 21)|Change in Transudation Rate of Albumin, Transudation rate of albumin calculated using the BVA-100 software. An increase indicates the transudation rate increased during the observational period., Day 1, Day of ICU Discharge (up to day 21)|Change in Heart Rate, Measured using PICCO. Heart rate expressed as beats per minute (BPM)., Day 1, Day of ICU Discharge (up to day 21)|Change in Cardiac Output, Measured using PICCO. Cardiac output expressed in liters per minute (L/min)., Day 1, Day of ICU Discharge (up to day 21)|Change in Stroke Volume, Measured using PICCO. Stroke volume expressed in milliliters per square meter (mL/m2)., Day 1, Day of ICU Discharge (up to day 21)|Change in Systemic Vascular Resistance (SVR), Measured using PICCO. SVR expressed in dynes/second/cm\^5., Day 1, Day of ICU Discharge (up to day 21)|Change in Global End Diastolic Volume (GEDV) Index, Measured using PICCO. GEDV expressed in mL/m2., Day 1, Day of ICU Discharge (up to day 21)|Change in Intra-Thoracic Blood Volume Index (ITBVI), Measured using PICCO. ITBVI expressed in mL/m2., Day 1, Day of ICU Discharge (up to day 21)|Change in Extravascular Lung Water (EVLW), Measured using PICCO. EVLW expressed in mL/kg., Day 1, Day of ICU Discharge (up to day 21)|Maximum Stroke Volume, Measured using PICCO. Stroke volume expressed in mL/m2., Up to Day of ICU Discharge (up to day 21)|Minimum Stroke Volume, Measured using PICCO. Stroke volume expressed in mL/m2., Up to Day of ICU Discharge (up to day 21)|Maximum Pulse Pressure, Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg)., Up to Day of ICU Discharge (up to day 21)|Minimum Pulse Pressure, Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg)., Up to Day of ICU Discharge (up to day 21)|Change in Systolic Blood Pressure, Measured using PICCO. Systolic blood pressure expressed in mmHg., Day 1, Day of ICU Discharge (up to day 21)|Change in Diastolic Blood Pressure, Measured using PICCO. Diastolic blood pressure expressed in mmHg., Day 1, Day of ICU Discharge (up to day 21)|Mean Blood Pressure, Measured using PICCO. Blood pressure expressed in mmHg., Up to Day of ICU Discharge (up to day 21)|Change in Central Venous Pressure (CVP), Measured using PICCO. CVP expressed in mmHg., Day 1, Day of ICU Discharge (up to day 21)","Number of Participants with New Onset Renal Injury, Up to Day of ICU Discharge (up to day 21)|Number of Participants Requiring Renal Replacement Therapy, Up to Day of ICU Discharge (up to day 21)",,NYU Langone Health,Daxor Corporation,ALL,"ADULT, OLDER_ADULT",,39,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,20-00896,2020-08-01,2023-04-09,2023-04-09,2020-08-18,,2023-09-21,"Uniformed Services University of the Health Sciences, Bethesda, Maryland, 20814, United States|NYU Langone Health, New York, New York, 10016, United States|Wake Forest Baptist Health, Winston-Salem, North Carolina, 27157, United States", NCT04724395,Disability Following Hospitalization in People of Working-age Surviving SARS-CoV-2 Infection - COVID-19,https://clinicaltrials.gov/study/NCT04724395,DisCOVID,RECRUITING,The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.,NO,COVID-19,OTHER: Hospitalization,"Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization, Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider, At 12 (±3) months after hospitalization|Post-acute COVID-19 disability from the care provider's perspective, 36 months after hospitalization, Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider, 36 (±3) months after hospitalization|Post-acute COVID-19 disability from the patient's perspectives, 12 months after hospitalization, Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), At 12 (±3) months after hospitalization|Post-acute COVID-19 disability from the patient's perspectives, 36 months after hospitalization, Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), 36 (±3) months after hospitalization","Type of treatments, Non-pharmacological / pharmacological treatments will be self-reported : ER consultations, specialist consultations, laboratory tests, new hospital stay, rehabilitation resource consumption, At 12 (±3) and 36 (±3) months after hospitalization|Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform), Anchor questions ( 2 questions), 12(±3) and 36 (±3) months after the first day of the first hospitalization.|Health-related quality of life (questionnaire self-administered on ComPARe IT dedicated platform), EuroQol : ED-5D-5L (5 themes of questions + a scale from 0 to 100, 100 is the best state of health), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Pain (questionnaire self-administered on ComPARe IT dedicated platform), Brief Pain Inventory (7 scales from 0 to 10 : 10 is the worst pain), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Impairments, activity limitations and participation restrictions, health-related quality of life Fatigue (questionnaire self-administered on ComPARe IT dedicated platform), Modified Fatigue Impact Scale (8 questions), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform), Hospital Anxiety and Depression Scale (14 questions with scales from 0 to 3), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform), Post-Traumatic Stress Disorder Checklist Scale (17 questions with a scale from 1 to 5), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform), Brain Injury Complaint Questionnaire (25 questions), 12 (±3), and 36 (±3) months after the first day of the first hospitalization.|Urinary symptoms, if applicable (questionnaire self-administered on ComPARe IT dedicated platform), Urinary Symptom Profile (10 questions), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Female sexual dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform), Female Sexual Function Index, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Erectile dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform), International Index of Erectile Function (5 questions with a scale from 0 to 5), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Global activity limitations and participation restrictions (questionnaire self-administered on ComPARe IT dedicated platform), 36-Item WHODAS 2.0, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Work Ability (questionnaire self-administered on ComPARe IT dedicated platform), Work Ability Index Single-Item 1 (1 question with a scale from 0 to 10, 10 is the highest ability to work), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Work productivity (questionnaire self-administered on ComPARe IT dedicated platform), Work Productivity and Activity Impairment questionnaire Single-Item 5 (1 question with a scale from 0 to 10, 10 is the worst productivity), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Comorbidities (score completed by the investigator during a face-to-face visit), Charlson comorbidity index (20 items), 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Impairments, activity limitations and participation restrictions (checklist completed by the investigator during a face-to-face visit), WHO ICF checklist v2.1, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Mobility test to assess the consequences of neurological, cardiorespiratory, osteoarticular or respiratory impairments (clinical assessment by the investigator during a face-to-face visit), 6 minute walk test, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Locomotor impairments (clinical assessment by the investigator during a face-to-face visit), Timed up and go test, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Upper extremities impairments (clinical assessment by the investigator during a face-to-face visit), Box and Block test, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Respiratory impairment (clinical assessment by the investigator during a face-to-face visit), MRC Dyspnoea scale, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Respiratory impairment (clinical assessment by the investigator during a face-to-face visit), NYHA grade, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Cognitive impairments (clinical assessment by the investigator during a face-to-face visit), Montreal Cognitive Assessment, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Cognitive impairments (clinical assessment by the investigator during a face-to-face visit), Frontal Assessment Battery, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Muscular impairments (clinical assessment by the investigator during a face-to-face visit), MRC-Sum Score, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Respiratory impairments (clinical assessment by the investigator during a face-to-face visit), Sustained Expiration while counting, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Muscular impairments (clinical assessment by the investigator during a face-to-face visit), Grip strength, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Muscular impairments (clinical assessment by the investigator during a face-to-face visit), Chair rise with arms, 12 (±3) and 36 (±3) months after the first day of the first hospitalization.|Total costs, 36 months after the first day of the first hospitalization.|Costs drivers, Total costs, cost ivers and estimated Years-Lived with Disability (YLDs), 36 months after the first day of the first hospitalization.|Estimated Years lived with Disability, 36 months after the first day of the first hospitalization.|Burden of post-acute COVID-19 on participant's close relative, Zarit Burden Inventory (22 questions with a scale from 0 to 4) (using printed version of specific self-administered questionnaires completed by the patient' close relative), Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.|Resource utilization, Resource Utilization in Dementia - Part I (3 items of questions) (using printed version of specific self-administered questionnaires completed by the patient' close relative), Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.|Symptoms of anxiety and/or depression of participant's close relative, Hospital Anxiety and Depression Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative), Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.|Symptoms of post-traumatic stress, Post-Traumatic Stress Disorder Check-list Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative), Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.",,Assistance Publique - Hôpitaux de Paris,,ALL,"ADULT, OLDER_ADULT",,800,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,P200601|2020-A02552-37,2021-03-31,2025-03,2025-09,2021-01-26,,2022-09-27,"Cochin Hospital, Paris, 75014, France", NCT04313023,The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2,https://clinicaltrials.gov/study/NCT04313023,,COMPLETED,"Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.",YES,COVID-19,DRUG: PUL-042 Inhalation Solution|DRUG: Placebo,"Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy., To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment.The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 28 days from the start of experimental therapy.The OSCI to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. The minimum score is 0, maximum is 8. Higher values represent a worse outcome.OSCI Scale:0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized \& requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7, 28 days","Percentage of SARS-CoV-2 Infections Through Day 29, Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit., 28 days|Percentage of SARS-CoV-2 Infections Through Day 15, Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit., 14 days|Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 14 Days From the Start of Experimental Therapy., To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment.The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 14 days from the start of experimental therapy.The Ordinal Scale for Clinical Improvement (OSCI) to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. Higher values represent a worse outcome.OSCI Scale: 0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized \& requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7 (requiring RRT, ECMO etc.), 8 (death)., 14 days|Number of Participants With ICU Admission, The requirement for ICU admission within 28 days from the start of experimental therapy., 28 days|Number of Participants Requiring Mechanical Ventilation, The requirement for mechanical ventilation within 28 days from the start of experimental therapy., 28 days|Number of Participant Deaths, All cause mortality at 28 days from the start of experimental therapy., 28 days",,"Pulmotect, Inc.",United States Department of Defense,ALL,"ADULT, OLDER_ADULT",PHASE2,217,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION",PUL-042-501,2020-06-09,2021-07-31,2021-07-31,2020-03-18,2023-05-17,2023-05-17,"University of California Irvine, Orange, California, 92868, United States|Premier Urgent Care of California, San Bernardino, California, 92404, United States|Clinical Research of South Florida Alliance for Multispecialty Research, Coral Gables, Florida, 33134, United States|Invesclinic US LLC, Fort Lauderdale, Florida, 33308, United States|Luminous Cinical Research- South Florida Urgent Care, Miami, Florida, 33136, United States|Entrust Clinical Research, Miami, Florida, 33156, United States|DBC Research, Tamarac, Florida, 33321, United States|Affinity Clinical Research, LLC, Tampa, Florida, 33612, United States|Clinical Research Atlanta, Stockbridge, Georgia, 30281, United States|Willis-Knighton Physcian Network, Bossier City, Louisiana, 71111, United States|Ascension St John, Bartlesville, Oklahoma, 74006, United States|Ascension St. John, Tulsa, Oklahoma, 74104, United States|Invesclinic US LLC, Edinburg, Texas, 78539, United States|MD Anderson Cancer Center, Houston, Texas, 77030, United States|Next Level Urgent Care, Houston, Texas, 77057, United States","Study Protocol and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/23/NCT04313023/Prot_ICF_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/23/NCT04313023/SAP_001.pdf" NCT04482595,BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients,https://clinicaltrials.gov/study/NCT04482595,,ACTIVE_NOT_RECRUITING,"This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung function in patients that were hospitalized for severe COVID-19-related illness and continue to experience post-acute respiratory complications associated with Long-COVID after discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.",NO,COVID-19|Long COVID|Pulmonary Fibrosis|Post-acute Respiratory Complications of COVID-19,DRUG: BIO 300 Oral Suspension|DRUG: Placebo,"Change in DLCO, Diffusing capacity of the lungs for carbon monoxide (DLCO), 12 Weeks","Change in 6 Minute Walk Test, 6 minute walk test (6MWT), 12 Weeks|Change in FVC, Forced vital capacity (FVC), 12 Weeks, 6 Months and 12 Months|Change in St. George's Respiratory Questionnaire (SGRQ) Scores, Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations., 12 Weeks, 6 Months and 12 Months|Change in Pulmonary Fibrosis on HRCT Scan, Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis, 12 Weeks, 6 Months and 12 Months|Incidence of Re-Hospitalization, Incidence of hospitalization after initial discharge and initiating treatment, 12 Months|All-Cause Mortality, Mortality at 12 months after initiating treatment, 12 Months|Change in FEV1, Forced expiratory volume in one second (FEV1), 12 Weeks, 6 Months and 12 Months|Change in FEV1/FVC Ratio, Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC), 12 Weeks, 6 Months and 12 Months|Change in 6 Minute Walk Test, 6 minute walk test (6MWT), 6 Months and 12 Months|Change in Pulse Oximetry at Rest and During the 6MWT, Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT), 12 Weeks, 6 Months and 12 Months|Change in DLCO, Diffusing capacity of the lungs for carbon monoxide (DLCO), 6 Months and 12 Months|Adverse Events Related to BIO 300 Oral Suspension, Evaluate the safety of BIO 300 Oral Suspension treatment, 12 Months|Change in Clinical Laboratory Values, Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL), 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months|Change in Clinical Laboratory Values, Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL), 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months|Change in Clinical Laboratory Values for Albumin, Monitoring of blood serum levels for albumin (g/dL), 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months|Change in Clinical Laboratory Values for Serum Enzymes, Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L), 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months|Change in Complete Blood Counts with Differential, Monitoring of white blood cell, red blood cell and platelet counts, 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months","Change in Supplemental Oxygen Use, Prescribed supplemental oxygen flow rate at night, rest and exertion, 12 Weeks, 6 Months and 12 Months|Change in Duration of Supplemental Oxygen Use, Duration of supplemental oxygen use, 12 Weeks, 6 Months and 12 Months|Change in Serum Cytokine Expression, Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1), 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months",Humanetics Corporation,NYU Langone Health|National Institute of Allergy and Infectious Diseases (NIAID),ALL,"ADULT, OLDER_ADULT",PHASE2,50,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",CL0105-01|272201800011C-P00005-9999-1,2020-11-11,2024-07-31,2025-04-30,2020-07-22,,2024-10-01,"University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|NYU Langone Health, New York, New York, 10016, United States|University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States|Houston Methodist Research Institute, Houston, Texas, 77210, United States", NCT04447495,Self-sampling for the Study of COVID-19,https://clinicaltrials.gov/study/NCT04447495,,COMPLETED,"This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. The investigators will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.",NO,Coronavirus,DIAGNOSTIC_TEST: iAMP test,"Validate iAMP testing kit, Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection., 1 month",,,Medical College of Wisconsin,,ALL,"ADULT, OLDER_ADULT",,126,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,20-001,2020-07-01,2020-12-31,2020-12-31,2020-06-25,,2021-12-23,"Mooreland Reserve Health Center, New Berlin, Wisconsin, 53151, United States", NCT04332094,Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19),https://clinicaltrials.gov/study/NCT04332094,TOCOVID,UNKNOWN,"COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.",NO,COVID-19,DRUG: Tocilizumab|DRUG: Hydroxychloroquine|DRUG: Azithromycin,"In-hospital mortality, Through hospitalization, an average of 2 weeks|Need for mechanical ventilation in the Intensive Care Unit, Through hospitalization, an average of 2 weeks",,,Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau,Instituto de Salud Carlos III,ALL,"ADULT, OLDER_ADULT",PHASE2,276,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,IIBSP-COV-2020-23,2020-04-02,2021-06,2021-07,2020-04-02,,2021-05-06,"Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain|Hospital General Universitario de Alicante, Alicante, Valencia, Spain|Hospital General Universitario de Elche, Elche, Valencia, Spain|Hospital de la Santa Creu i Sant Pau, Barcelona, Spain|Hospital del Mar, Barcelona, Spain|Hospital Sant Joan Despí, Barcelona, Spain|Hospital Clinico San Carlos, Madrid, Spain", NCT04979091,Sex Hormone Dysregulations Are Associated With Critical Illness in COVID-19 Patients,https://clinicaltrials.gov/study/NCT04979091,HAM-SEX-C19,COMPLETED,"Males develop more severe SARS-CoV-2 infection related disease outcome than females. Herein, sex hormones were repeatedly proposed to play an important role in Covid-19 pathophysiology and immunity. However, it is yet unclear whether sex hormones are associated with Covid-19 outcome in males and females. In this study, we analyzed sex hormones, cytokine and chemokine responses as well as performed a large profile analysis of 600 metabolites in critically-ill male and female Covid-19 patients in comparison to healthy controls and patients with coronary heart diseases as a prime Covid-19 comorbidity. We here show that dysregulated sex hormones, IFN-γ levels and unique metabolic signatures are associated with critical illness in Covid-19 patients. Both, male and female Covid-19 patients, present elevated estradiol levels which positively correlates with IFN-γ levels.Male Covid-19 patients additionally display severe testosterone and triglyceride deficiencies as compared to female patients and healthy controls. Our results suggest that male Covid-19 patients suffer from multiple metabolic disorders, which may lead to higher risk for fatal outcome. These findings will help to understand molecular pathways involved in Covid-19 pathophysiology.",NO,Covid19|Critical Illness,DIAGNOSTIC_TEST: Sex Hormones,"Sex hormone in critical ill COVID-19 patients, testosterone, Day at admission|Sex hormone in critical ill COVID-19 patients, estradiol, Day at admission|Sex hormone in critical ill COVID-19 patients, sex hormone-binding globulin, Day at admission|Sex hormone in critical ill patients, testosterone, Day at admission|Sex hormone in critical ill patients, estradiol, Day at admission",,,Universitätsklinikum Hamburg-Eppendorf,"Federal Ministry of Health, Germany",ALL,"ADULT, OLDER_ADULT",,100,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,HAM-SEX-C19,2020-03-08,2021-02-26,2021-05-31,2021-07-27,,2021-08-06,"University Medical Center, Hamburg, 20246, Germany", NCT05131594,Evaluating the Response of the Immune System of People with Long COVID (post SARS-CoV-2),https://clinicaltrials.gov/study/NCT05131594,LCRC,ENROLLING_BY_INVITATION,"Many people who have had COVID 19 continue to experience symptoms long after they have recovered from the acute infection. This study will examine the clinical symptoms of people with ""Long COVID"" and measure various markers of inflammation in their blood.",NO,COVID-19,,"Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC), Do patient symptoms correlate with abnormalities in inflammatory profiles?, From onset of infection to 24 months|Identification of immunologic and inflammatory features of PASC based on results of immunologic and inflammatory assays, Are there abnormalities in immunologic and inflammatory assays unique to PASC?, From onset of infection to 24 months|Evaluation and delineation of the pathologic pathways and long-term effects of SARS-CoV2 infection, What are the pathological pathways and long-term effects of SARS-CoV2?, From onset of infection to 60 months|Identification of risks factor for PASC, What are the risk factors for PASC?, From onset of infection to 24 months|Identification of potential sites of therapeutic intervention to ameliorate symptomatology of PASC, Are there potential sites of therapeutic intervention to relieve the symptoms of PASC?, From onset of infection to 60 months",,,Huntington Memorial Hospital,San Diego Biomedical Research Institute,ALL,"ADULT, OLDER_ADULT",,100,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,Pro00054801,2021-10-13,2025-06,2026-06,2021-11-23,,2024-09-19,"Huntington Hospital, Pasadena, California, 91105, United States", NCT05052294,COVID-19 Antibody Responses in Cystic Fibrosis,https://clinicaltrials.gov/study/NCT05052294,CAR-CF,ACTIVE_NOT_RECRUITING,"Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom and other countries. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.",NO,Cystic Fibrosis,,"SARS-COV-2 seroprevalence, proportion of pwCF with at least 1 seropositive result over the study period and the difference in this proportion by age, geographical area and over time, 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)|Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF, incidence of symptomatic COVID-19 over the study period and severity; proportion of seropositive pwCF with subsequent CF exacerbation compared to pwCF who are seronegative; death rate in pwCF with at least one seropositive result compared to pwCF who are seronegative, 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)|Longitudinal comparison of the detection, including level and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and SARS-CoV-2 vaccination, 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)","Serum proteomic and genomic responses of pwCF, who are SARS-CoV-2 seropositive an seronegative, anticipated 5-10 years",,"University Hospital, Motol",Brno University Hospital,ALL,"CHILD, ADULT, OLDER_ADULT",,50,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,531/21,2021-09-13,2025-06-01,2025-06-01,2021-09-22,,2025-03-30,"Brno University Hospital, Brno, 61300, Czechia|University Hospital Motol, Prague, 15006, Czechia", NCT04603729,Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease,https://clinicaltrials.gov/study/NCT04603729,covid19,COMPLETED,"The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.",NO,Covid 19 Disease,DRUG: Dexamethasone 2 MG/ML|DRUG: Methylprednisolone Injection,"temperature (F), reduction in temperature in degree farrenheit, 5 days|oxygen saturation(%), reduction in oxygen requirement in lit/min, 5 days|CRP (mg/dl), mean reduction in CRP mg/dl in 5 days, 5 days|mortality, number of patients died, 5 days|ICU transfer, number of patients shifted to ICU, 5 days",,,Fatima Memorial Hospital,,ALL,"ADULT, OLDER_ADULT",PHASE3,100,OTHER,INTERVENTIONAL,Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,FMH-06-2020-IRB-763-M,2020-05-30,2020-06-30,2020-07-01,2020-10-27,,2020-10-27,"Fatima Memorial Hospital, Lahore, Punjab, 54700, Pakistan", NCT04885491,"A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension",https://clinicaltrials.gov/study/NCT04885491,,WITHDRAWN,"This is an open-label, multicentre study evaluating the effect, safety and tolerability of the two regioisomers 1-(nitrosooxy)propan-2-ol and 2-(nitrosooxy)propan-1-ol (PDNO) infusion given to COVID-19 patients with acute pulmonary hypertension (aPH) and/or acute cor pulmonale (ACP).",NO,Pulmonary Hypertension|COVID-19,DRUG: Sodium chloride (placebo)|DRUG: PDNO,"Change in MPAP and calculated PVR measured with PAC, at target dose after up-titration and 10 minutes after steady state., Mean pulmonary arterial pressure (MPAP) and pulmonary vascular resistance (PVR), as measured with a pulmonary artery catheter (PAC)., During 24 hours","Safety and tolerability of PDNO in patients with COVID-19, as measured by incidence of treatment-emergent AEs, SAEs, and AESI., * Treatment-emergent adverse events (AEs)* Treatment-emergent serious AEs (SAEs)* Treatment-emergent AEs of special interest (AESI), Through study completion (i.e., Day 30)|Safety and tolerability of PDNO in patients with COVID-19, as measured by incidence of treatment-emergent changes in vital signs, ECG abnormalities, and laboratory abnormalities., * Treatment-emergent changes in vital signs (blood pressure, pulse, oxygen saturation, respiratory frequency, body temperature)* Treatment-emergent electrocardiogram (ECG) abnormalities* Treatment-emergent laboratory abnormalities, From baseline until Day 7|Number of participants with the following clinical outcome (dead, intubated at the intensive care unit [ICU], non-intubated at the ICU, discharged from ICU to other hospital care or discharged to home)., At Days 7, 14, 21, and 30.|Time to obtain first negative upper respiratory tract sample in the SARS-CoV-2-rt-PCR assay, From Day 1 to Day 14|Change in troponin I/T and BNP/NT-proBNP, From end of PDNO infusion to Day 7.|Change in the ratio PVR/SVR, Pulmonary vascular resistance (PVR) and systemic vascular resistance (SVR) will be calculated from the obtained values according to the following formulas:PVR= (mean pulmonary arterial pressure \[MPAP\] - pulmonary capillary wedge pressure \[PCWP\])/cardiac output (CO) SVR= (mean arterial pressure \[MAP\] - central venous pressure \[CVP\])/CORatio of PVR to SVR = PVR/SVR, During 24 hours","Levels of SARS-CoV-2 virus in plasma and sputum/tracheal secretion, From Day 1 to Day 2|Collection of plasma for future analysis of biomarkers such as nitrite and nitrate in plasma (µM), From Day 1 to Day 7",Attgeno AB,Vinnova,ALL,"ADULT, OLDER_ADULT",PHASE1|PHASE2,0,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,2020-PDNO-002,2021-05-07,2023-04-30,2023-04-30,2021-05-13,,2023-08-01,"Danderyd Hospital, Danderyd, 182 88, Sweden|Örebro University Hospital, Örebro, 701 85, Sweden", NCT05729191,Evaluation of the Acceptance of the Anti-COVID-19 Vaccine Offer Among Pregnant Women,https://clinicaltrials.gov/study/NCT05729191,,COMPLETED,"The SARS-CoV-2 pandemic still represents a global health, social and economic emergency. In Italy, since the beginning of the pandemic, a total of 4,709,753 cases and 131,461 deaths have been recorded.The vaccination campaign against COVID-19, launched on 27 December 2020, has made it possible in Italy to achieve complete vaccination coverage (two doses) of 80.6% of the population aged \> 12 years. The latest data on the impact of vaccination in preventing new infections, hospitalizations and deaths report a strong reduction in the risk of SARS-CoV-2 infection in fully vaccinated people compared to unvaccinated people (78% for diagnosis, 92% for hospitalization, 95% for ICU admissions and 94% for deaths); most of the cases notified in the last 30 days in Italy have been diagnosed in unvaccinated people2.Evidence on the immunogenicity and safety of anti-SARS-CoV-2 vaccination in pregnant women, although not deriving from clinical trials, is growing, even if not yet conclusive. On the efficacy of mRNA vaccines in pregnancy, a retrospective Israeli cohort study reported a significantly lower risk of contracting SARS-CoV-2 infection compared to unvaccinated women. Furthermore, a greater maternal and perinatal morbidity from COVID-19, also associated with the circulation of the Delta variant, has been highlighted by the recent analyzes of the English data, updated to 11 July 2021.The Istituto Superiore di Sanità, in the light of the growing evidence on the safety of vaccination during pregnancy for both the fetus and the mother, the new evidence relating to the greater morbidity associated with the Delta variant, the growing circulation of the same variant and the significant lowering of median age at infection in Italy, recommends extending the vaccine offer, with mRNA vaccines, to all pregnant women in the second and third trimester.Objectives of the study: Evaluate the quality in terms of reception of the anti-COVID-19 vaccine offer, the knowledge and attitudes towards the aforementioned vaccination by pregnant women who join the Vaccination Open Day and who access the FPG Covid Vaccination Center for this vaccination.Primary endpoint: Measuring acceptance of the anti-COVID-19 vaccine offer and knowledge about vaccination, by means of a questionnaire to be administered after vaccination.",NO,Pregnant Women|COVID 19 Vaccine|Vaccination Hesitancy,BIOLOGICAL: Anti Covid 19 vaccination campaign for pregnat women,"Compliance and knowledge, Measure the acceptance of the anti-COVID-19 vaccine offer and knowledge about vaccination, by means of a questionnaire to be administered after vaccination., 2021-2022",,,Fondazione Policlinico Universitario Agostino Gemelli IRCCS,,FEMALE,ADULT,,100,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,4557,2021-10-25,2022-03-30,2022-03-30,2023-02-15,,2023-02-16,"Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00168, Italy", NCT04932876,The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19,https://clinicaltrials.gov/study/NCT04932876,,UNKNOWN,"Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.",NO,End Stage Kidney Disease|Kidney Transplantion|Covid19|Vaccination,BIOLOGICAL: SARS - COV 2 VACCINE,"Efficacy of the vaccine, Humoral immune response to the vaccine as evaluated by generation of SARS-CoV-2 IgG II antibodies at two time points (before the second dose of the BNT162b2 vaccine and two weeks following the second dose of the BNT162b2 vaccine). Secondly, lympocyte subsets will be measured by flow cytometry (Naive and memeory T cells - CD45RO+, CD45 RA+, CD4+RO+, CD4+CDRA+, CD4+, CD8+, CD19+, NKT cells) at the two respective time points so as to assess alterations induced by vaccination. Serologic response will be estimated by measurement of anti SARS-CoV-2-spike IgGII titer (AU/ml) in the serum (using the ARCHITECT IgG II Quant test (Abbott); titers \>50 arbitrary units (AU)/ml are considered positive (detection range, 6.8-80,000 AU/ml); positive agreement, 99.4%; negative agreement, 99.6%)., 24 months","Complications caused by the vaccine, Potential side effects associated with the vaccine shall be recorded. Percentages of lymphocytes subsets (as depicted before) in peripheral blood will be measured by flow cytometry. We will compare changes from baseline in the percentages of the lymphocytes subsets following the first and second dose of vaccination between the hemodialysis and kidney transplant recipeints group. In addition we will search for associations between percentages of lymphocytes subsets at diggerent measurement time points and antibody reponse., 24 months",,University of Ioannina,,ALL,"ADULT, OLDER_ADULT",,100,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,RESCOMUOI82152,2021-04-24,2021-12,2023-03,2021-06-21,,2021-09-29,"Evangelia Ntounousi, Ioannina, Epirus, 45110, Greece", NCT04481360,Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut University Hospital,https://clinicaltrials.gov/study/NCT04481360,,UNKNOWN,* Evaluation of the clinical presentation of COVID 19 pneumonia.* Identification the risk factors of severing COVID 19 pneumonia.* Evaluation of the outcome of the disease.,NO,Coronavirus,DEVICE: CT of the chest,"Clinical evaluation, Patients assessment using CURB 65\|(confusion ,urea level, respiratory rate blood pressure,age above 65 years) score 0 or 1 out patient -2 inpatient observation- 3 or more ICU admission., through study completion, an average of 1 year",,,Assiut University,,ALL,"ADULT, OLDER_ADULT",,100,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,Presentation of COVID19 in AUH,2020-08,2021-08,2021-09,2020-07-22,,2020-07-22,, NCT04494776,SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study,https://clinicaltrials.gov/study/NCT04494776,,RECRUITING,"COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in a national multicenter cohort.",NO,SARS-CoV-2 Infection|Kidney Transplant Infection,,"Death, Death within 3 months after infection (Yes/No)., Up to 3 months after resolution|Graft loss, Graft loss up to 3 months after infection (Yes/No)., Up to 3 months after resolution","Hospitalization, Composite outcomes: Mechanical ventilation (Yes/No); Need for dialysis (Yes/No); Need for ICU admission during evolution (Yes/No)., Until discharge date, an average of 1 month",,Helio Tedesco Silva Junior,Hospital do Rim e Hipertensão,ALL,"CHILD, ADULT, OLDER_ADULT",,500,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,30631820.0.1001.8098,2020-05-21,2022-12-03,2025-04-02,2020-07-31,,2024-11-08,"Hospital do Rim, São Paulo, Aão Paulo, 04038-002, Brazil", NCT05331976,A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test,https://clinicaltrials.gov/study/NCT05331976,,COMPLETED,"To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2 Assay for diagnosing SARS-CoV-2 infection.",NO,COVID-19|Asymptomatic COVID-19,DIAGNOSTIC_TEST: Proof Lab Test System,"Positive and Negative Percent Agreement, The primary outcome measure will be positive and negative percent agreement (PPA and NPA) of the candidate device in a point-of-care setting to the authorized molecular comparator., Two weeks","Ratio of Positive Predictive Value to Negative Predictive Value, Determine the likelihood ratio of positive predictive value to likelihood ratio negative predictive value, standard positive predictive value, and standard negative predictive value. Additionally, discrepant test results found between the Proof Test and the Quidel Comparator Test will be analyzed via an independent EUA approved test for final adjudication., Two Weeks",,Proof Diagnostics,ICON Clinical Research|MRI Global|ASCLEPES Research Center|Eastside Research Associates|PMG Research of Piedmont Healthcare,ALL,"CHILD, ADULT, OLDER_ADULT",,276,INDUSTRY,OBSERVATIONAL,Observational Model: |Time Perspective: p,PDx-2233-01,2022-02-09,2022-03-21,2022-03-21,2022-04-18,,2022-04-25,"Asclepes Research Center, Spring Hill, Florida, 34609, United States|PMG Research of Piedmont Healthcare, Statesville, North Carolina, 28625, United States|Eastside Research Associates, Redmond, Washington, 98052, United States", NCT04386460,Covid-19 and Prevention of Malnutrition After Confinement by Dentists,https://clinicaltrials.gov/study/NCT04386460,,COMPLETED,"Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:",NO,Nutrition Poor|Infection Viral|Oral Disease,,"Body Mass Index, Body Mass Index evolution from baseline, 1 Month|Body Mass Index, Body Mass Index evolution from baseline, 3 Months","Weight changes during confinement, Usual weight at baseline vs weight before confinement (gk), 8 weeks|prescription of nutritional supplements and observance, number and type of nutritional supplements from baseline, 3 months",,Centre Hospitalier Universitaire de Nice,,ALL,"ADULT, OLDER_ADULT",,17,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,20odontocovid-02,2020-05-11,2020-06-05,2021-05-11,2020-05-13,,2025-02-17,"University Nice Hospital, Nice, 06000, France", NCT04726176,COVID-19 and the Brain,https://clinicaltrials.gov/study/NCT04726176,,COMPLETED,"The main objective of this project is:1. To assess the impact of COVID-19 on the brain and executive functioning.Twenty adult subjects of UZ Brussels (volunteers), who needed intensive care due to COVID-19 (n=10) or exhibited mild symptoms due to COVID-19 (n=10), will be recruited after hospital discharge. After signing an informed consent the subjects will undergo brain scans (T1, DTI, SWI, DWI, FLAIR MRI and rsfMRI), an emotion regulation task and a neurocognitive test battery. The latter test battery will be performed using an iPad and will test different neurocognitive functions such as memory, abstract thinking, spatial orientation and attention. The duration of the test battery is 18min. The total duration of one trial is estimated at one hour and a half. All tests are planned at the department of Radiology-Magnetic Resonance (UZ Brussel). After three months patients will visit the department of Radiology-Magnetic Resonance a second time for the same experimental trial. Additionally, a matched control group (n = 20; non covid or ICU patients) will be included and undergo the same tests in order to compare the results of the brain scans, emotional regulation task and neurocognitive test battery with results of both Covid-groups. Next to objective data, questionnaires will be filled out, i.e. visual analogue scales of mental and physical fatigue, Profile of Mood States and some additional return to work questions.",NO,Covid19|Brain|Neurocognition|fMRI,BIOLOGICAL: Exposure to COVID-19,"Brain scans, T1, FLAIR MRI, SWI, DWI, DTI, rsfMRI and a task-based functional MRI, Up to 12 weeks|Neurocognitive test battery, The computerized cognitive test battery ""Cognition"" will be conducted using an iPad. This cognitive test battery is sensitive to multiple domains at high-level cognitive performance. It consists of the motor praxis test (measure of sensorimotor speed), visual object learning test (measure of spatial learning and memory), abstract matching (measure of abstraction), line orientation test (measure of spatial orientation), digit symbol substitution test (measure of complex scanning and visual tracking), balloon analogue risk test (measure of risk decision making), NBACK (measure of working memory) and psychomotor vigilance test (measure, or vigilant attention) and takes approximately 18 min in total., Up to 12 weeks","Emotion regulation task, During the last brain scan, i.e. the task-based functional fMRI, a short emotion regulation task will be employed. Twenty negatively rated stimuli from the International Affective Picture System balanced on arousal (exciting/calm) will be randomly allocated to one of two blocks, one block per condition (experiential awareness, i.e. switching attention towards the bodily felt affective experience / cognitive reappraisal i.e. cognitively changing how one appraises the situation represented on the negative pictures)., Up to 12 weeks|Mental fatigue Visual Analogue Scale (M-VAS), Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue), Up to 12 weeks|Physical fatigue Visual Analogue Scale (P-VAS), Subjective measure of physical fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue), Up to 12 weeks|Return to work questionnaire, Questionnaire encompassing the following questions:1. When did you restart work duties after hospital discharge?2. Did you consider yourself fit to return to work?3. What is your general experience of restart working?4. Have you been equally as productive, less productive, or more productive than before the COVID-19 infection/since the former consultation?, Up to 12 weeks|Profile of Mood States (POMS), The Profile of Mood States (POMS) is a 65 item self-report psychological instrument. The POMS measures six different dimensions of mood states over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. These 65 items are rated on a five-point scale ranging from ""not at all"" to ""extremely""., Up to 12 weeks",,Vrije Universiteit Brussel,Universitair Ziekenhuis Brussel,ALL,"ADULT, OLDER_ADULT",,40,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,1432020000338,2021-01-30,2021-12-01,2021-12-01,2021-01-27,,2022-04-29,"Vrije Universiteit Brussel, Brussels, 1050, Belgium", NCT06911476,From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19,https://clinicaltrials.gov/study/NCT06911476,LIBERATE,NOT_YET_RECRUITING,"Rationale: The diagnosis and pathogenesis of long COVID remains unknown. We have previously shown that \[68Ga\]FAPI Positron Emission Tomography-Computed Tomography (PET/CT) imaging shows potential for diagnosis and molecular understanding of this syndrome. We have previously shown that fibroblast activation protein (FAP) can be imaged in the lung, muscle and nasopharynx of long COVID patients (with dyspnea and fatigue). However, these preliminary data are derived from a selective group of patients with long COVID after critical COVID-19. We aim to explore the generalizability of these findings in patients with long COVID with dyspnea and fatigue, irrespective of the severity of their acute SARS-CoV-2 infection.Primary objective: To assess if pulmonary fibroblast activity, measured by \[68Ga\]FAPI-46 PET/CT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints.Study design: This is a ZonMw funded single centre prospective observational cohort study of long COVID-19 patients with dyspnea and fatigue.Study population: We will recruit 60 adult long COVID patients (aged \>20 years) of which 30 have complaints of dyspnea and fatigue and compare them to 30 patients with resolved complaints and healthy controls.Main study parameters/endpoints: The primary endpoint is FAP expression in the lung measured by \[68Ga\]FAPI-46 PET/CT. Secondary endpoints are the expression of FAP in other tissues (muscle) and the relation between FAP and inflammation and remodelling biomarkers in various biological samples (e.g. serum/nasal epithelium).Study procedures: In a single visit day the following data and samples will be collected: questionnaires, a lung function test, 6-minute walking test, blood samples, nose swabs, \[68Ga\]FAPI PET/CT scan and HRCT scan. When increased \[68Ga\]FAPI uptake is measured in the muscles a muscle biopsy will be performed as well.",NO,PASC Post Acute Sequelae of COVID 19|Long COVID|Long Covid-19|PASC|FAPI|FAP|Fibroblast Activation Protein Inhibitor|Fibroblast|Restrictive Lung Disease,,"Pulmonary FAP expression, To compare pulmonary FAP expression between patients with persistent PASC and patients recovered from PASC. Pulmonary FAP expression will be measured via the pulmonary FAPI uptake on the \[68Ga\]FAPI-46 PET/CT scan. Uptake is measured as whole lung SULmean (standardized uptake value corrected for lean body mass) corrected for the background signal (bloodpool). Resulting in the target-to-background ratio (TBR) of the whole lung., Day 1","Whole body FAP expression, To compare whole body FAPI uptake in patients with persistent PASC vs patients recovered from PASC. Whole body FAPI uptake is measured in the muscle via automated segmentation. Mean muscle uptake values are calculated., Day 1|Pulmonary FAP expression vs clinical endpoints, To compare pulmonary FAPI uptake (expressed as the mean of the whole lung) to clinical endpoints (e.g. lung function, 6-minute walking test (6-MWT) and self-reported daily impairments assessed by several questionnaires)., Day 1|Whole body FAP expression vs clinical endpoints, To compare whole body FAPI uptake (expressed as the mean of the whole lung) to clinical endpoints (e.g. 6-minute walking test (6-MWT) and self-reported daily impairments assessed by several questionnaires)., Day 1|Serum biomarkers, To explorer serum biomarkers (e.g. soluble FAP and cytokines/growthfactors) and cellular phenotypes of inlammation and remodelling in relation to FAPI uptake (expressed as TBRmean of the whole lung)., Day 1","HRCT vs pulmonary FAP expression, Visual assessment of HRCT abnormalities matching pulmonary FAPI uptake., Day 1|Muscle biopsies, Patients willing to give additional informed consent for a muscle biopsy will be evaluated for increased muscle FAPI uptake (SUVmax of \>4.5). In these patients an ultrasound guided muscle biopsy will be performed of a high uptake area (\>4.5 SUV) and a low uptake area (\<4 SUV). Tissue examination as well as single cell RNA analysis will be performed to explorer the relation between FAP expression and activated remoddeling programs., Day 1",University Medical Center Groningen,Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA),ALL,"ADULT, OLDER_ADULT",,60,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,19097|ZonMW|2024-511294-29-00,2025-05,2025-12,2025-12,2025-04-04,,2025-04-04,, NCT04738760,Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients,https://clinicaltrials.gov/study/NCT04738760,,COMPLETED,"Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19 adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D lead to pulmonary permeability reduction by modulating RAS activity as well as the expression of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage.Additionally, vitamin D had shown antiviral effects on several previous studies, that though to be exerted either by antimicrobial peptides induction which subsequently had direct antiviral action or through immunomodulatory and anti-inflammatory effects.In addition, vitamin D stabilizes physical barriers which prevent viruses from reaching tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic cardiovascular and respiratory diseases, and cancers, all medical conditions that are considered risk factors of COVID-19 infection deterioration and even high mortality rate.The objective of this study is to evaluate whether supplementation with high-dose vitamin D improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of vitamin D.",NO,Covid19|Corona Virus Infection|Cytokine Storm|Vitamin D Deficiency,,"Duration of hospitalization, Length of hospital stay, Two weeks|In-hospital mortality, Death during hospitalization, Two weeks|Clinical status improvement using six category ordinal scale, Change in six category ordinal scale. The categories were defined as follows: 1) patient discharged, 2) hospitalization not requiring supplemental oxygen, 3) hospitalization requiring supplemental low-flow oxygen, 4) hospitalization requiring high-flow supplemental oxygen, 5) hospitalization requiring invasive mechanical ventilation, 6) death., Two weeks|Change in gas exchange, Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge, Two weeks|Time to increase in oxygenation, Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2), 48 hours","Change in Lactate dehydrogenase (LDH) levels, Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge, Two weeks|Change in C-reactive protein (CRP) levels, Change in levels of C-reactive protein (CRP) between baseline and before discharge, Two weeks|Change in serum ferritin levels, Change in levels of serum ferritin between baseline and before discharge, Two weeks|Occurrence of secondary infection, Occurrence of sepsis, Two weeks|Occurrence of at least one severe adverse event, Any serious or severe adverse event that might happens during hospital stay, Two weeks|Need for mechanical ventilator or intensive care unit (ICU) support, Admission to ICU or usage of mechanical ventilator, Two weeks",,Ain Shams University,Misr International University,ALL,"ADULT, OLDER_ADULT",,116,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,COVID-VIT-D,2020-12-01,2021-06-01,2021-08-01,2021-02-04,,2022-07-20,"Teachers Hospital, Cairo, Please Select, 11314, Egypt", NCT04909476,Tracheal Intubation in COVID-19 Patients,https://clinicaltrials.gov/study/NCT04909476,,UNKNOWN,"The Emergency Endotracheal intubation of a patient who is COVID-19 positive is a high-risk procedure and an additional challenge to an intensivist due to barrier enclosures that have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation. Although the incidence of difficult airways is commonly higher in critically ill patients, the evidence of severe hypoxemia without sign of respiratory distress could complicate the scenario.This silent hypoxia often leads to a delayed recognition of the severity of respiratory failure and to a late intubation which is often characterized by a high risk of complications related to the actual airways' management, hemodynamic and cardiac. It has been shown that non-survivors had worse blood gas analyzes than survivors, both before and after intubation. Few studies have reported the implications and adverse events of performing endotracheal intubation for critically ill COVID-19 patients admitted to intensive care units (ICUs).",NO,COVID-19 Pneumonia|Tracheal Intubation,PROCEDURE: Endotracheal intubation,"Major adverse peri-intubation events, The incidence of major adverse peri-intubation events defined as least one events:* cardiovascular instability* severe Hypoxemia* cardiac arrest, intubation procedure, an expected average 30 minutes","Number of minor complications in the intubation process in patients admitted in the intensive care, This study will analyze the prevalence of minor complications related to intubation technique in the the Critical Unit. This information will be useful in order to determinate the risk factors associated., 28 days|Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy, Although the video laryngoscope is useful to perform difficult airways management, the benefits associated to its employment is still controversial compared to the conventional laringoscope., 28 days",,St. Bortolo Hospital,Fondazione IRCCS Policlinico San Matteo di Pavia,ALL,"ADULT, OLDER_ADULT",,143,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,125/20,2020-11-17,2021-05-20,2021-06-10,2021-06-01,,2021-06-04,"San Matteo Hospital, Pavia, Lombardia, 27100, Italy|San Bortolo Hospital, Vicenza, Veneto, 36100, Italy", NCT06850376,COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus,https://clinicaltrials.gov/study/NCT06850376,,COMPLETED,"This pragmatic trial aims to evaluate whether a weekly self-help virtual reality protocol can help overcome the psychological burden of the COVID-19 pandemic. The protocol is based on 'The Secret Garden' 360° VR video available online (www.covidfeelgood.com) which simulates a natural environment to promote relaxation and self-reflection. The VR experience is combined with daily cognitive and social exercises designed to facilitate critical examination of personal identity, relationships, and coping strategies. The study assesses whether this intervention can reduce anxiety, depression, perceived stress, and hopelessness while improving well-being and social connectedness during pandemic-related restrictions.",NO,COVID-19 Pandemic Psychological Impact|Stress|Anxiety Disorders|Depression|Social Isolation,BEHAVIORAL: COVID Feel Good VR Self-Help Protocol|OTHER: Waiting Period,"Change in depression, anxiety, and stress levels as measured by Depression Anxiety Stress Scale (DASS-21), The Depression Anxiety Stress Scale (DASS-21) is a self-report questionnaire consisting of 21 items divided into three subscales that measure depression, anxiety, and perceived stress. Each subscale can be computed individually or added together into a score for general distress. Higher scores indicate greater symptoms of depression, anxiety, and stress. The scale will be used to assess changes in psychological distress associated with the COVID-19 pandemic before and after the VR self-help intervention., Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)|Perceived Stress Scale (PSS-10), A scale measuring subjective perception of stress during the past week, Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)|Change in hopelessness levels, A scale measuring pessimistic attitudes toward the future, Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)","Change in social connectedness, A scale measuring sense of connection to others and to the social context, Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)|Change in fear of coronavirus, A scale measuring level of fear related to the COVID-19 pandemic, Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)|Change in relaxation levels during intervention, A scale measuring relaxation and perceived stress during the intervention, Daily during intervention (Days 1-7)|Change in subjective distress during intervention, A scale measuring level of perceived distress, Daily during intervention (Days 1-7)",,Istituto Auxologico Italiano,Clemson University (Virtual Reality and Nature Lab)|University of Barcelona|University of Tsukuba|Konkuk University|University of Bergen|University of Liege|Catholic University of the Sacred Heart,ALL,"ADULT, OLDER_ADULT",NA,36,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,39C001,2020-04-01,2021-10-01,2021-12-31,2025-02-27,,2025-02-27,"IRCCS Istituto Auxologico Italiano, Milano, Lombardia, 20145, Italy", NCT04334629,LIBERATE Trial in COVID-19,https://clinicaltrials.gov/study/NCT04334629,LIBERATE,WITHDRAWN,The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.,NO,Coronavirus|Respiratory Distress Syndrome|SARS-CoV Infection,DRUG: Ibuprofen,"Disease progression, Worsening respiratory failure; defined using severity of hypoxaemia using \[PaO2/FiO2 ratio OR SpO2/FiO2 ratio\], 14 days|Time to mechanical ventilation, Time to mechanical ventilation (or need of), 14 days","Overall survival, 28 days|Reduction in proportion of patients who require ventilation, 28 days|Reduction in length of Critical Care stay, 28 days|Reduction in length of Hospital stay, 28 days|Modulation of serum pro- and anti-inflammatory cytokines, 28 days|Reduction in duration of ventilation, 28 days|Increase in ventilator-free days, 28 days",,King's College London,,ALL,"ADULT, OLDER_ADULT",PHASE4,0,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",282009,2020-05-26,2021-05-25,2021-09-25,2020-04-06,,2023-07-25,"Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom", NCT05760092,The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19.A Randomized Controlled Trial.,https://clinicaltrials.gov/study/NCT05760092,,COMPLETED,"Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) as a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2). Long COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that persists after the acute infection has resolved. The most frequent symptoms of Lonf-term COVID are fatigue and dyspnea. But two classes of symptoms have been received scientific attention: the musculoskeletal pain and oral complaints related to Long COVID, mainly xerostomia and burning mouth. Photobiomodulation (PBM) therapy is often used for oral diseases and presents itself as a non-invasive, low-cost, safe therapy that has benefits in relation to the quality of life of patients with xerostomia. This study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia and oral complaints related to Long-Covid. This will be a single-center, randomized, controlled, blinded clinical trial that will involve patients with Long COVID in follow-up at the Medical and Multiprofessional outpatient clinic of University Nove de Julho (UNINOVE) which remained hospitalized with COVID-19 at Lydia Storópoli Universitarian Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022. All those patients presenting xerostomia, burning mouth or oral complaints related to Long Covid will be randomized into 2 groups: PBM Group (standard rehabilitation treatment for Long COVID and xerostomia + PBM therapy) or PBM placebo group (standard rehabilitation treatment for Long COVID and xerostomia + placebo PBM therapy). PBM consists of the application of Red LED on the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, 3 J/cm2, for 36 seconds, twice a week for 06 weeks. Functional and quality of life evaluations will be perform pre and post therapy period.",NO,Xerostomia|COVID-19|Long COVID|Persistent COVID-19,COMBINATION_PRODUCT: Institutional standard treatment for xerostomia and Long Covid|RADIATION: Photobiomodulation Therapy|RADIATION: Placebo Photobiomodulation Therapy,"Brazilian version of the SF 36 Quality of Life Scale, Assessment of general quality of life, translated and validated for the Brazilian population, composed of assessments in the following domains: functional capacity, limitation due to physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health., pre-treatment and post-treatment moment (after 04 weeks of treatment)|Nutritional assessment, Anthropometric measurements of body weight, height and calculation of the Body Mass Index (BMI) according to the World Health Organization (WHO) reference standard for adults and Lipschitz criterion for elderly patients., pre-treatment and post-treatment (after 04 weeks of treatment)|Salivary ph, Stimulated salivary flow and unstimulated salivary flow, Total salivary flow rates (SFRs) at rest and during stimulation will be determined according to the guidelines for unstimulated and stimulated total saliva collection provided by Navazesh and Kumar (1993). To characterize hyposalivation, investigators will use the Sreebny criterion (2000) according to which the abnormal salivary flow is lower than 0.1 ml/min without stimulation and 0.5 ml/min with stimulation. Salivary pH (unstimulated salivary flow) will also be evaluated, which will be performed using pH indicator paper tape, color scale ranging from 0.0 to 14.0 (gradation 1.0; precision 0.2) The strips will be dipped in samples of saliva for 5 min. Then the test fields of the strips will be compared with the color scales. Whereas healthy saliva must have a pH between 6.5 to 7.4., pre-treatment and post-treatment (after 04 weeks of treatment)|Oral Health Impact Profile (OHIP-14), Assessment of Oral Health-related Quality of Life, by OHIP-14 , translated and validated for Brazilian population, pre-treatment and post-treatment (after 04 weeks of treatment)|Xerostomia Inventory XI, A multi-item approach to measuring and quantify dry mouth., pre-treatment and post-treatment (after 04 weeks of treatment)|Functional Independence Measure (FIM), A translated and validated for the Brazilian population of general assessment of functional independence, pre-treatment and post-treatment (after 04 weeks of treatment)|Post-Covid-19 Functional Status Scale, A tool to measure the full spectrum of functional outcomes following COVID-19., pre-treatment and post-treatment (after 04 weeks of treatment)|The World Health Organization Disability Assessment Schedule (WHODAS 2.0), The World Health Organization Disability Assessment Schedule (WHODAS 2.0) was designed to assess the functioning level in six life domains (cognition, mobility, selfcare, getting along, life activities, and participation in community activities), pre-treatment and post-treatment (after 04 weeks of treatment)",,,University of Nove de Julho,,ALL,"CHILD, ADULT, OLDER_ADULT",PHASE2,10,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",Covidlongasusy,2023-03-01,2024-02-01,2024-03-08,2023-03-08,,2024-03-12,"Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences, Sao Paulo, Brazil", NCT04481529,COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector,https://clinicaltrials.gov/study/NCT04481529,SEROCO,UNKNOWN,"Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this ""COVID-19 wave"", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers.This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate.Since june 2020, all staff in French health establishments could benefit a serological test.Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.",NO,Infection Viral,OTHER: Health Questionnaire,"Number of subjects with a COVID-19 seroconversion, Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver)., through study completion, an average of 5 month",,,"University Hospital, Limoges",,ALL,"ADULT, OLDER_ADULT",,1576,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,87RI20_0049/SEROCO,2020-07-29,2020-12-15,2021-01-15,2020-07-22,,2021-01-13,"CH Argenteuil - Service de Réanimation, Argenteuil, 95107, France|Ch Belfort, Belfort, 90000, France|CHU Dijon - Serve de Réanimation, Dijon, 21079, France|CHU de Limoges, Limoges, France", NCT04425629,"Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19",https://clinicaltrials.gov/study/NCT04425629,,TERMINATED,"Phase 1* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2Phase 2• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2Phase 3* Cohort 1 (≥18 Years Old, Not Pregnant at Randomization) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death* Cohort 2 (\<18 Years Old, Not Pregnant at Randomization) * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To further characterize the concentrations of REGN10933 and REGN10987 in serum over time* Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987",YES,COVID-19,DRUG: casirivimab+imdevimab combination therapy,"Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3], Primary:Phase 1, Phase 3 (Cohort 2 and Cohort 3)Secondary:Phase 2, Phase 3 (Cohort 1), Through Day 29|Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3), Primary:Phase 1, Phase 3 (Cohort 2 and Cohort 3)Secondary:Phase 2, Phase 3 (Cohort 1), Through Day 4|Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3), Primary:Phase 1, Phase 3 (Cohort 2 and Cohort 3)Secondary:Phase 2, Phase 3 (Cohort 1), Through Day 29|Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2), Primary:Phase 1, Phase 2, Baseline up to Day 7|Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo), Primary:Phase 3 (Cohort 1), Through Day 29|Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2), Phase 3 Cohort 2\[Nominal Sampling Time\] = \[Clinical Study Time (Visit Day - 1)\], Up to Nominal Sampling Day 28","Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo), Phase 3 Cohort 1, Up to Day 29|Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo), Phase 3 (Cohort 1), Through Day 29|Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo), Phase 3 (Cohort 1), Day 4 thru Day 29|Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo), Phase 3 (Cohort 1), From Day 4 Through Day 29|Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort), Next Phase 2 Symptomatic, Day 5, Day 7, Day 15, Day 29|Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2), Phase 1, Phase 2, Day 1 to Day 29|Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2), Phase 1, Phase 2, Through Day 29|Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2), Phase 1, Phase 2, Through Day 29|Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only), Phase 2 Only, Up to Day 29|Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV, Phase 3 Cohort 1 - Placebo vs. 1.2 g IV, Through Day 29|Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV, Phase 3 (Cohort 1), Through day 29|Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3), Secondary:Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants\[Nominal Sampling Time\] = \[Clinical Study Time (Visit Day - 1)\], Up to Nominal Sampling Day 28|Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1), Phase 1 Only, Through Day 29|Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1), Phase 1 Only, Through Day 29|Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1), Phase 1 Only, Through Day 29|Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1), Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants, Through Day 29|Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3), Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants, Through Day 29|Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1), Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants, Through Day 29|Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3), Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants, Through Day 29|Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3), Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants(TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay, Through Day 29|Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3), Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants(TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay, Through Day 29|Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2), Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits, Through Day 29|Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV, Phase 3 (Cohort 1), Through Day 29|Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV, Phase 3 Cohort 1, Through Day 29|Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2), Phase 1 and Phase 2, Through Day 29|Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only), Phase 1 Only, Through Day 29|Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only), Phase 1 Only, Though Day 29|Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only), Phase 1 Only, Through Day 29|Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only), Phase 1 Only - Tlast (Time of last quantifiable concentration), Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Day 4 Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Day 4 Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Through Day 29|Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Through Day 29|Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Through Day 29|Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Through Day 29|Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Through Day 29|Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1, Through Day 29|Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1, Through Day 29|Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g, Phase 3 Cohort 1, by Day 29, Day 120, and Day 169|Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g, Phase 3 Cohort 1 Placebo vs. 2.4g IV, by Day 29, Day 120, and Day 169|Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only), Next Phase 2 Only, Through Day 29|Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only), Phase 1 Only, Up to Day 29|Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only), Phase 1 Only, Baseline Up To Day 29|Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only), Phase 1 Only, Baseline Up to Day 29|Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only), Phase 1 Only, Up To Day 29|Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1), Phase 1 Only, Baseline up to Day 22|Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only), Phase 2 Only, Through Day 29|Duration of Symptoms Consistent With COVID-19 (Phase 2 Only), Phase 2 Only, Through Day 29|Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only), Phase 2 Only, Through Day 29|Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2), Phase 1, Phase 2, Through Day 29|Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only), Phase 1 Only, Through Day 29|Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic), Phase 2 Asymptomatic, Through Day 29|Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo), Phase 3 Cohort 1 (1.2g IV), Through Day 169|Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo), Phase 3 Cohort 1 (2.4g IV), Through Day 169|Time to All-cause Death (Phase 3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo), Through Day 29|Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo), Through Day 29|Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo), Phase 3 Cohort 1, Baseline up to Day 29|Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo), Phase 3 Cohort 1, Baseline up to Day 29|Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2), Phase 3 Cohort 2, Baseline up to Day 29|Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1), Phase 3 (Cohort 1), Baseline to Day 7|Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2), Phase 3 (Cohort 2), Baseline to Day 7|Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only), Next Phase 2 Symptomatic, Day 0, Day 5, Day 7, Day 15, Day 29|Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only), Next Phase 2 Symptomatic, Day 0, Day 5, Day 7, Day 15, Day 29|Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV, Phase 3 (Cohort 1), Through Day 29|Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV, Phase 3 (Cohort 1), Through Day 29|Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic), Phase 2 Only, Up to Day 29|Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV, Phase 3 (Cohort 1), Through Day 29|Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV, Phase 3 (Cohort 1), Through Day 29|Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2), Phase 3 (Cohort 2), Through Day 29|Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87, Next Phase 2, Through Day 29|Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g, Phase 3 Cohort 1, Through Day 29|Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g, Phase 3 Cohort 1, Through Day 29|Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2), Phase 3 Cohort 2, Through Day 29",,Regeneron Pharmaceuticals,,ALL,"CHILD, ADULT, OLDER_ADULT",PHASE3,10078,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,R10933-10987-COV-2067|2020-003690-21,2020-06-16,2022-01-21,2022-06-09,2020-06-11,2023-12-21,2023-12-21,"Regeneron Study Site, Mesa, Arizona, 85210, United States|Regeneron Study Site, Tucson, Arizona, 85712, United States|Regeneron Study Site, Tucson, Arizona, 85724, United States|Regeneron Study Site, Canoga Park, California, 91303, United States|Regeneron Study Site, La Mesa, California, 91942, United States|Regeneron Study Site, La Palma, California, 90623, United States|Regeneron Study Site 1, Long Beach, California, 90806, United States|Regeneron Study Site 2, Long Beach, California, 90806, United States|Regeneron Study Site 3, Long Beach, California, 90806, United States|Regeneron Study Site, Los Angeles, California, 90036, United States|Regeneron Study Site, Montclair, California, 91763, United States|Regeneron Study Site, Rolling Hills Estates, California, 90274, United States|Regeneron Study Site, Sacramento, California, 95817, United States|Regeneron Study Site, San Francisco, California, 94127, United States|Regeneron Study Site, Santa Monica, California, 90404, United States|Regeneron Study Site, Stanford, California, 94305, United States|Regeneron Study Site, Aurora, Colorado, 80045, United States|Regeneron Study Site, Colorado Springs, Colorado, 80907, United States|Regeneron Study Site, Washington, District of Columbia, 20037, United States|Regeneron Study Site, Boca Raton, Florida, 33487, United States|Regeneron Study Site, DeLand, Florida, 32720, United States|Regeneron Study Site, Fort Pierce, Florida, 34982, United States|Regeneron Study Site, Hialeah, Florida, 33010, United States|Regeneron Study Site, Loxahatchee Groves, Florida, 33470, United States|Regeneron Study Site, Maitland, Florida, 32751, United States|Regeneron Study Site, Miami, Florida, 33012, United States|Regeneron Study Site 1, Miami, Florida, 33126, United States|Regeneron Study Site 2, Miami, Florida, 33126, United States|Regeneron Study Site, Miami, Florida, 33130, United States|Regeneron Study Site, Miami, Florida, 33144, United States|Regeneron Study Site, Miami, Florida, 33184, United States|Regeneron Study Site, Saint Petersburg, Florida, 33705, United States|Regeneron Study Site, Sarasota, Florida, 34239, United States|Regeneron Study Site, Tampa, Florida, 33606, United States|Regeneron Study Site, West Palm Beach, Florida, 33407, United States|Regeneron Study Site, Winter Haven, Florida, 33880, United States|Regeneron Study Site, Winter Park, Florida, 32789, United States|Regeneron Study Site, Atlanta, Georgia, 30309, United States|Regeneron Study Site, Atlanta, Georgia, 30322, United States|Regeneron Study Site, Augusta, Georgia, 30912, United States|Regeneron Study Site, Columbus, Georgia, 31904, United States|Regeneron Study Site, Marietta, Georgia, 30060, United States|Regeneron Study Site, Chicago, Illinois, 60607, United States|Regeneron Study Site 1, Downers Grove, Illinois, 60515, United States|Regeneron Study Site 2, Downers Grove, Illinois, 60515, United States|Regeneron Study Site, Downers Grove, Illinois, 60515, United States|Regeneron Study Site, Ames, Iowa, 50010-3014, United States|Regeneron Study Site, Iowa City, Iowa, 52242, United States|Regeneron Study Site, Lake Charles, Louisiana, 70601, United States|Regeneron Study Site, Marrero, Louisiana, 70072, United States|Regeneron Study Site, New Orleans, Louisiana, 70114, United States|Regeneron Study Site, Shreveport, Louisiana, 71118, United States|Regeneron Study Site, Baltimore, Maryland, 21201, United States|Regeneron Study Site, Royal Oak, Michigan, 48073, United States|Regeneron Study Site, Jackson, Mississippi, 39216, United States|Regeneron Study Site, Las Vegas, Nevada, 89109, United States|Regeneron Study Site, Ridgewood, New Jersey, 07450, United States|Regeneron Study Site, Teaneck, New Jersey, 07666, United States|Regeneron Study Site, Santa Fe, New Mexico, 87505, United States|Regeneron Study Site, Bronx, New York, 10451, United States|Regeneron Study Site, Bronx, New York, 10461, United States|Regeneron Study Site, Jamaica, New York, 11432, United States|Regeneron Study Site, New York, New York, 10003, United States|Regeneron Study Site, New York, New York, 10019, United States|Regeneron Study Site, New York, New York, 10025, United States|Regeneron Study Site, New York, New York, 10029, United States|Regeneron Study Site, New York, New York, 10032, United States|Regeneron Study Site, New York, New York, 10037, United States|Regeneron Study Site, Charlotte, North Carolina, 28209, United States|Regeneron Study Site, Durham, North Carolina, 27710, United States|Regeneron Study Site, Wilmington, North Carolina, 28401, United States|Regeneron Study Site, Columbus, Ohio, 43215, United States|Regeneron Study Site, Dayton, Ohio, 45409, United States|Regeneron Study Site, Dayton, Ohio, 45432, United States|Regeneron Study Site, Philadelphia, Pennsylvania, 19140, United States|Regeneron Study Site, Providence, Rhode Island, 02903, United States|Regeneron Study Site, Charleston, South Carolina, 29425, United States|Regeneron Study Site, Clinton, South Carolina, 29325, United States|Regeneron Study Site, Sioux Falls, South Dakota, 57108, United States|Regeneron Study Site 2, Memphis, Tennessee, 38103, United States|Regeneron Study Site, Memphis, Tennessee, 38103, United States|Regeneron Study Site, Amarillo, Texas, 79109, United States|Regeneron Study Site, Corpus Christi, Texas, 78413, United States|Regeneron Study Site, Dallas, Texas, 75246, United States|Regeneron Study Site, Dallas, Texas, 75390, United States|Regeneron Study Site, Houston, Texas, 77004, United States|Regeneron Study Site, Houston, Texas, 77008, United States|Regeneron Study Site, Houston, Texas, 77030, United States|Regeneron Study Site, Houston, Texas, 77055, United States|Regeneron Study Site, Houston, Texas, 77057, United States|Regeneron Study Site, Houston, Texas, 77093, United States|Regeneron Study Site, Pearland, Texas, 77584, United States|Regeneron Study Site, Red Oak, Texas, 75154, United States|Regeneron Study Site, San Antonio, Texas, 78215, United States|Regeneron Study Site, San Antonio, Texas, 78217, United States|Regeneron Study Site, San Antonio, Texas, 78249, United States|Regeneron Study Site, Tyler, Texas, 75708, United States|Regeneron Study Site, Falls Church, Virginia, 22042, United States|Regeneron Study Site, Everett, Washington, 98201, United States|Regeneron Study Site, Seattle, Washington, 98109, United States|Regeneron Study Site, Seattle, Washington, 98122, United States|Regeneron Study Site, Madison, Wisconsin, 53792, United States|Regeneron Study Site, Guadalajara, Jalisco, 44280, Mexico|Regeneron Study Site, Guadalajara, Jalisco, 44340, Mexico|Regeneron Study Site, Zapopan, Jalisco, 45070, Mexico|Regeneron Study Site, Monterrey, Nuevo Leon, 64718, Mexico|Regeneron Study Site, Monterrey, Nuevo León, 64710, Mexico|Regeneron Study Site, Merida, Yucatan, 97070, Mexico|Regeneron Study Site, Chihuahua, 31238, Mexico|Regeneron Study Site, Ciudad de Mexico, 3100, Mexico|Regeneron Study Site, Durango, 34000, Mexico|Regeneron Study Site, Mérida, 97000, Mexico|Regeneron Study Site, Veracruz, 91900, Mexico|Regeneron Study Site, Bucuresti, 021105, Romania","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/29/NCT04425629/Prot_001.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/29/NCT04425629/SAP_002.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/29/NCT04425629/ICF_000.pdf" NCT05000229,Residual Symptoms After Coronavirus Disease (COVID-19) in Lithuanian Population,https://clinicaltrials.gov/study/NCT05000229,Post-Covid,UNKNOWN,"The aim of the study is to describe the post-covid-19 syndrome in Lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation.",NO,Post-Covid Syndrome,,"Description of post-covid-19 syndrome in Lithuanian population, Post-covid-19 syndrome in Lithuanian population: prevalence, symptomatology and needs of rehabilitation, 2021.05.04 - 2022.12.31","Assessment of medical premorbid status in post-covid-19 syndrome, The severity of comorbidities in terms of self-reported medical diagnoses and medication, 2021.05.04 - 2022.12.31",,Lithuanian University of Health Sciences,Karolinska Institutet,ALL,"ADULT, OLDER_ADULT",,5000,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,001/Version 1,2021-05-04,2022-12-31,2022-12-31,2021-08-11,,2021-08-11,"Lithuanian University of Health Sciences, Kaunas, 44307, Lithuania", NCT04887129,Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD),https://clinicaltrials.gov/study/NCT04887129,,COMPLETED,"The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe.Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19.The study lasts for up to 16 months.",YES,Covid19,DIAGNOSTIC_TEST: COVID-19 RT-PCR test|OTHER: COVID-19 Vaccine Education Campaign,"Number Infected With COVID-19, Number of students or staff who test positive for COVID-19 at least once using a nasal swab test., 16 months|Change in the Percentage of Participants Reporting Anxiety, Anxiety will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having anxiety if they were moderate or severe., baseline to 16 months|Change in the Percentage of Participants Classified as Depressed, Depression was measured using the PROMIS-29 assessment. Students or staff were classified within normal range, mild, moderate or severe. They were counted as having depression if they were moderate or severe., baseline to 16 months|Change in the Percentage of Participants Classified With Fatigue, Fatigue will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having fatigue if they were moderate or severe., baseline to 16 months|Change in Percentage of Participants With Deficits in Social Functioning, Social functioning will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having social functioning deficits if they were moderate or severe., baseline to 16 months",,,University of Rochester,Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD),ALL,"CHILD, ADULT, OLDER_ADULT",NA,392,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH,STUDY00005294|OT2HD107553-01,2021-05-03,2023-08-31,2024-03-31,2021-05-14,2025-02-03,2025-02-03,"Mary Cariola Center, Rochester, New York, 14620, United States","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/29/NCT04887129/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/29/NCT04887129/SAP_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/29/NCT04887129/ICF_002.pdf" NCT04565392,Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19),https://clinicaltrials.gov/study/NCT04565392,Pepcid4COV19,WITHDRAWN,"Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and with study drug is overnighted to qualified subjects with early symptoms of COVID-19. Subjects take a 20-milligram (mg) tab of famotidine or matching placebo twice a day, increase to 1 tablet every 8 hours if not better the 2nd day, and continue same for 30 days. Vital signs, symptoms, compliance etc are rechecked daily for the 30 days and once again 60 days after starting study drug. Consent, baseline, and follow-up are handled via internet plus calls/texts/virtual visits from study nurse or doctor as needed for clarifications and compliance.",NO,Covid19,DRUG: Famotidine 20 milligram tablet,"Clinical Course Binary Outcome, Proportion of patients who self-rate as 6 on Patients Global Impression or are hospitalized for COVID-19 or similar symptoms or seek medical help for worsening symptoms, or get short of breath and have oxygen saturation below 90%, or die of COVID-19, 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward|Serious Adverse Events, Proportion of patients who report a serious adverse event, i.e., one that causes hospitalization or death, 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward]","Time to symptomatic recovery, Proportion who answer the daily Global Recovery Question affirmatively: ""Have you returned to your usual health (before your COVID-19 illness)? yes/no"" if verified on the same day's evaluation by at least one category of improvement in each of the symptoms endorsed at baseline on the SCL18 (see Outcome 4)., There is no baseline rating. Outcome is rated on the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward|SCL18 (self-check list of 18 symptoms of COVID-19), a) mean change in total (18-item) score since baseline; b) proportion self-rating each item (symptom) at a lower or 0 intensity value than at baseline; c) subtotal on: Major Acute Physical Symptoms (SCL18 #2, Pains in heart or chest, #4 Nausea, vomiting or upset stomach, #6 Sore throat, #7 Cough, #9 Chills or shivering, #11 Diarrhea, or #13, Trouble getting your breath), d) physical symptoms (first 13 items of SCL18), f) cognitive symptoms (last 5 items of SCL18). Each item is rated as (0) not at all, (1) a little bit (2) moderately, (3) quite a bit, or (4) extremely, Change from baseline at 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward|Patient's Global Impression of Change, Proportions rating Patient's Global Impression of Change: as 1-4; as 1-3; as 1-2; as 6 (answer set: 1, very much improved, 2/much improved, 3/moderately improved, 4/minimally improved, 5/about the same, 6/worse), There is no rating at baseline. Outcome is for the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward|Adverse Events, Proportions of patients reporting new or worsening symptoms: a) any adverse event; b) the expected adverse events for famotidine (headache, dizziness, constipation, diarrhea); c) other adverse events, grouped by type, 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward|Day-60 Follow-up, Each of the same endpoints as above but evaluated 30 days after the end of treatment, 60 days after the start of treatment",,drpykessupplements.com,,ALL,"ADULT, OLDER_ADULT",PHASE4,0,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",Pykonsult 201,2021-05-01,2021-11-01,2022-01-31,2020-09-25,,2021-12-20,"Pykonsult headquarters, New Fairfield, Connecticut, 06812, United States", NCT04349592,Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19,https://clinicaltrials.gov/study/NCT04349592,,COMPLETED,"Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.",NO,Covid19,DRUG: Hydroxychloroquine|DRUG: Azithromycin|OTHER: Placebo Tablet|OTHER: Placebo capsules,"Proportion of virologically cured (PCR-negative status) as assessed on day six, Days, Day 6","virologic cure on other study days, Days, Day14 and Day 21|virologic semiquantitative analysis of changing viral load, Days, Day 1 to Day 21|proportion of initially symtomatic subjects with disappearance of clinical symptoms, Days, Day14 and Day 21|proportion of initially asymtomatic subjects with appearance of new clinical symptoms, Days, Day14 and Day 21|proportions of subjects with potentially medication- related adverse events, grades, 7 day",,Hamad Medical Corporation,,ALL,"ADULT, OLDER_ADULT",NA,456,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",MRC-05-001,2020-04-14,2020-08-14,2020-08-30,2020-04-16,,2021-02-23,"Hamad Medical Corporation, Doha, 3050, Qatar", NCT04909892,"Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 ""Long Haul"" Pulmonary Compromise",https://clinicaltrials.gov/study/NCT04909892,,WITHDRAWN,"This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 ""long haulers"" with pulmonary compromise.",NO,Covid19,BIOLOGICAL: COVI-MSC,"Change in 6-Minute Walk Distance (6MWD) at Day 60, Change in 6MWD at Day 60, Baseline to Day 60","Change in 6MWD at Day 30, Change in 6MWD at Day 30, Baseline to Day 30|Change in Pulmonary Function Tests (PFTs), Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO), Baseline to Day 30 and Day 60|Change in oxygenation, Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio, Baseline to Day 30 and Day 60|Change in biomarker levels, Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor, Baseline through Day 30",,"Sorrento Therapeutics, Inc.",,ALL,"ADULT, OLDER_ADULT",PHASE2,0,INDUSTRY,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,MSC-PLH-201,2021-08,2022-01,2022-01,2021-06-02,,2021-09-16,, NCT04446429,Anti-Androgen Treatment for COVID-19,https://clinicaltrials.gov/study/NCT04446429,,COMPLETED,This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection,YES,COVID-19|SARS-CoV2|Androgenetic Alopecia|Prostate Cancer|Benign Prostatic Hyperplasia|SARS (Severe Acute Respiratory Syndrome),DRUG: Proxalutamide|OTHER: Standard of Care,"COVID-19 Hospitalization, Percentage of subjects hospitalized due to COVID-19, 30 days",,,"Applied Biology, Inc.",,MALE,"ADULT, OLDER_ADULT",NA,268,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",AB-DRUG-SARS-004,2020-10-21,2020-12-24,2021-01-21,2020-06-24,2021-02-03,2021-12-10,"Corpometria Institute, Brasilia, 70390-150, Brazil","Study Protocol and Statistical Analysis Plan: Study Protocol (English Translation), https://cdn.clinicaltrials.gov/large-docs/29/NCT04446429/Prot_SAP_001.pdf" NCT04407429,Vienna Versus SARS-CoV-2 Virus Study,https://clinicaltrials.gov/study/NCT04407429,VIVI,UNKNOWN,This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.,NO,SARS-CoV-2|COVID-19,DIAGNOSTIC_TEST: Laboratory Analyses,"Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time, 1 year","Incidence rate of sero-conversion, 1 year|Identification of risk markers/factors for SARS-CoV-2 infection, 1 year",,Medical University of Vienna,,ALL,"CHILD, ADULT, OLDER_ADULT",,12000,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,EK 1387/2020,2020-05-27,2021-06-27,2021-06-27,2020-05-29,,2020-05-29,"Medical University of Vienna, Vienna, 1090, Austria", NCT05449392,Topical Antibacterial Agents for Prevention of COVID-19,https://clinicaltrials.gov/study/NCT05449392,,COMPLETED,The primary objective of this study is to determine whether intranasal application of aminoglycoside (Neosporin) increases local nasal innate immune responses compared to placebo control in healthy participants.,NO,COVID-19|SARS-CoV2 Infection,DRUG: Neosporin|OTHER: Vaseline,"Change in in interferon response profile from nasal samples collected measured by a multiplex ELISA assay, Measurement of interferon response from samples collected using a multiplex ELISA to detect which interferon-stimulated genes (ISGs) are present in sample. ISGs measured include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl, From baseline up to Month 1|Change in in interferon response gene expression profile from nasal samples collected measured by RT-PCR, Measurement of interferon response from samples collected using RT-PCR to detect expression of ISGs. ISGs measured include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl, From baseline up to Month 1|Change in RNA expression profile of ISGs using RNAseq assay, In a subset of subjects in both arms, RNAseq will be performed to assess the presence and quantity of RNA on samples collected at Day 1 and Day 8. ISGs assessed include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl, Day 1and Day 8|Change in RNA expression profile of ISGs using single cell RNAseq assay, In a subset of subjects in both arms, single cell RNAseq will be performed to assess the presence and quantity of RNA on single cells from samples collected at Day 1 and Day 8. ISGs assessed include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl, Day 1 and Day 8",,,Yale University,Bill and Melinda Gates Foundation,ALL,ADULT,PHASE1,67,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION",2000032248|INV-038276,2022-09-01,2023-09-22,2023-09-22,2022-07-08,,2023-10-03,"Yale University, New Haven, Connecticut, 06520, United States", NCT04554992,Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019),https://clinicaltrials.gov/study/NCT04554992,,UNKNOWN,"This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.",NO,Covid19,BIOLOGICAL: COVID 19 Convalescent Plasma,"Cumulative incidence of serious adverse events related to the treatment intervention., Total number of grade 3 and above throughout study period, up to 60 days post-transfusion|Mortality at Day 28 post-hospital admission., All cause mortality at day 28, up to 28 days post-transfusion","Length of hospital stay, Total number of days subjects are hospitalized during study period, up to 60 days post-transfusion|Length of supplemental oxygen requirement., Total number of days subjects requires supplemental oxygen during study period, up to 60 days post-transfusion|Length of mechanical ventilation requirement., Total number of days subjects require mechanical ventilation during study period, up to 60 days post-transfusion|Length of ICU stay, Total number of days subject is subject stays in the ICU, up to 60 days post-transfusion",,The Methodist Hospital Research Institute,,ALL,"ADULT, OLDER_ADULT",PHASE1,350,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,00025121,2020-03-20,2022-06,2022-06,2020-09-18,,2020-11-02,"Houston Methodist Hopsital, Houston, Texas, 77030, United States", NCT04682873,"A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19, Caused by the SARS-CoV-2 Virus",https://clinicaltrials.gov/study/NCT04682873,,COMPLETED,"Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction \[RT-PCR\]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial.Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29.The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (Es).Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.",NO,Covid-19 Disease,DRUG: Enisamium Iodide|DRUG: Placebo,"Efficacy - Time from day of randomization to an improvement of at least two points (from the status at randomization) on severity rating (SR) scale in days, Time from day of randomization to an increase of at least two points (from the status at randomization) on the following severity rating (SR) scale in days:1. - Death2. - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)3. - Hospitalized, on non-invasive ventilation or high flow oxygen devices4. - Hospitalized, requiring supplemental oxygen5. - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise)6. - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care7. - Not hospitalized, limitation on activities and/or requiring home oxygen8. - Not hospitalized, no limitations on activities, Day 0 to Day 29","Efficacy - Time to recovery (TTR) from Day 1 (randomization and start of IMP treatment), Time to recovery (TTR) from day of randomisation: Day of recovery is defined as the first day on which the subject satisfies one of the following 3 categories from the ordinal scale (same scale being used as for the primary endpoint):6 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7 - Not hospitalized, limitation on activities and/or requiring home oxygen 8 - Not hospitalized, no limitations on activities, Day 0 to Day 29|Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge, Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge, whichever comes first: TTCR is defined as the time (Days) from randomisation (active or placebo) until normalization of fever, respiratory rate, oxygen saturation, and cough, sustained for at least 48 hours. Normalization and alleviation criteria:* Fever ≤37.2°C* Respiratory rate - ≤24/minute on room air* Oxygen saturation - \>94% on room air* Cough: absent, Day 0 to Day 29|Sum of Severity Rating from Day 2 to Day 15 (SSR-15), Sum of Severity Rating from Day 2 to Day 15 (SSR-15): Daily reporting of severity rating on an 8-point ordinal scale. The ordinal scale is an assessment of the clinical status starting from initiation of study treatment (active or placebo) from Day 2 to Day 15. The scale from 1 to 8 as defined for the primary endpoint., Day 2 to Day 15|Severity Rating on Day 15 (SR-15):, Severity Rating on Day 15 (SR-15): Reporting of severity rating on Day 15 or Day of discharge whichever occurs first on an 8-point ordinal scale. The ordinal scale is an assessment of the clinical status. The scale is defined from 1 (Death) to 8 (Not hospitalized, no limitations on activities) as defined for the primary endpoint., Day 15 or Day of discharge (whichever occurs first)|Days Alive and Out of Hospital until Day 15 (DAOH-14), The number of days alive and discharged from hospital until day 15 will be calculated for each group and the treatment differences displayed., Day 2 to Day 15|Proportion of Subjects Discharged by Day 8, 15, 22, 29, The proportion of subjects discharged by Day 8, 15, 22 and 29 will be displayed for the two treatment groups., Day 0 to Day 29|Incidence of non-invasive ventilation, The analysis of the incidences of non-invasive ventilation will be performed by logistic regression model with the binary outcome as dependent variable, age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors., Day 0 to Day 29|Days until non-invasive ventilation, The days until non-invasive ventilation will be calculated and the treatment differences displayed using the stratified log-rank test., Day 0 to Day 29|Total days of non-invasive ventilation, The total days of non-invasive ventilation will be evaluated by the generalized linear model based on the Poisson distribution and including age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors into the model., Day 0 to Day 29|Incidence of invasive mechanical ventilation or ECMO, The analysis of the incidence rate of invasive mechanical ventilation will be performed by logistic regression model with the binary outcome as dependent variable, age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors., Day 0 to Day 29|Days until invasive mechanical ventilation or ECMO, The days until invasive mechanical ventilation or ECMO will be calculated and the treatment differences displayed using the stratified log-rank test., Day 0 to Day 29|Course of qualitative RT-PCR viral test results, The course of qualitative RT-PCR virus test results will be evaluated by logistic regression with virus test as dependent variable, age as covariate, baseline severity rating, day, centre, treatment as fixed factors. In addition the interaction terms treatment x day and treatment x centre will be included as interaction term as fixed effect into the model. The treatment x day interaction term should detect any differences between treatments in the time until virus deletion., Day 0 to Day 29|Viral test evaluation - Proportion of subjects free of SARS-CoV-2, Proportion of subjects SARS-CoV-2 free pharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29, Days 0, 8, 15, 22, 29|Overall assessment of efficacy (patient and investigator), The investigator and the subject (each separately) will assess the overall (global) efficacy of the IMP, based on the change in symptoms using a Four-point verbal rating scale (VRS-4) (0=no symptoms / cured, 1=symptoms improved compared to Visit 1, 2=symptoms unchanged compared to Visit 1, 3=symptoms deteriorated compared to Visit 1)., Day 29 or Day of discharge (whichever occurs first)|Adverse events (AEs), Evaluate AEs by time of onset, actions taken, pattern of occurrence, and outcome, Day 0 to Day 29|Overall assessment of tolerability of treatment (patient and investigator), Difference in the global tolerability judgement scores on Day of Discharge from hospital (or Day 29, end of trial, if not discharged earlier).The investigator and the subject (each separately) will assess the overall (global) tolerability of the IMP using a five-point rating scale (0=very good, 1=good, 2=moderate, 3=poor, 4=very poor)., Day 29 or Day of discharge (whichever occurs first)",,"Joint Stock Company ""Farmak""",,ALL,"ADULT, OLDER_ADULT",PHASE3,592,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",FK/FAV00А-CoV/2020,2020-05-15,2021-03-26,2021-03-26,2020-12-24,,2021-12-29,"Municipal Enterprise ""Volyn Regional Clinical Hospital"" of Volyn Regional Council, Dept. Pulmonology, Lutsk, Volynsk, 43024, Ukraine|Municipal Non-Commercial Enterprise 'City Clinical Hospital #3' Chernivtsi City Council, Dept. Therapeutics #1, Dept. Therapeutics #2, Higher State Educational Institution of Ukraine 'Bukovinian State University', Chernivtsi, 58002, Ukraine|Municipal Non-Commercial Enterprise 'Regional Clinical Infection Hospital Ivano-Frankivsk Regional Council', Dept. #2, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, 76007, Ukraine|Municipal Non-Commercial Enterprise 'Regional Clinical Hospital Ivano-Frankivsk Regional Council', Dept. Allergology, Ivano-Frankivsk, 76008, Ukraine|Municipal Non-Commercial Enterprise 'City Clinical Hospital #1 Ivano-Frankivsk City Council', Dept. Therapeutics, Ivano-Frankivsk, 76018, Ukraine|Municipal Non-Commercial Enterprise Kharkiv Regional Council 'Regional Clinical Infection Hospital', 1st Department, Kharkiv National Medical University, Chair of Infectious Diseases, Kharkiv, 61096, Ukraine|Municipal Non-Commercial Enterprise 'Olexandrivska Clinical Hospital of Kyiv' Executive Authority of Kyiv City Council, Dept. Infections, Kyiv, 01601, Ukraine|Municipal Non-Commercial Enterprise ""Kyiv City Clinical Hospital #9"" Executive Authority of Kyiv City Council, Dept. Infections, Kyiv, 04112,, Ukraine|Municipal Non-Commercial Enterprise Lviv Regional Council 'Lviv Regional Infection Hospital', Fourth Diagnostic Department, Lviv, 79010, Ukraine|Ukraine Medical Stomatological Academy, Chair of Infectious Diseases with Epidemiology, Municipal Non-Commercial Enterprise 'Poltava Regional Infection Hospital Poltava Regional Council', Dept. Respiratory Infections, Poltava, 36011, Ukraine|Municipal Non-Commercial Enterprise 'Central Clinical Hospital' of Rivne City Council, Hepatic Centre - Infections, Rivne, 33018, Ukraine|Municipal Non-Commercial Enterprise 'Regional Clinical Infectional Hospital' Transcarpathian Regional Council, Dept. Infections (Adult), Uzhhorod, 88017, Ukraine|Municipal Non-Сommercial Enterprise 'Vinnytsya City Clinical Hospital #1', Infectious Department, National Pirogov Memorial Medical University, Dept. Infections, Vinnytsya, 21021, Ukraine",