873 matching studies

Sponsor Condition of Interest
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against...
BioNTech SE SARS-CoV-2 Infection COVID-19
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an... expand

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).

Type: Interventional

Start Date: Apr 2020

open study

A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus...
Hoffmann-La Roche COVID-19 Pneumonia
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia. expand

This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.

Type: Interventional

Start Date: Jun 2020

open study

Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age...
Sanofi Pasteur, a Sanofi Company COVID-19 (Healthy Volunteers)
The primary objectives of the study are: - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. - To describe the safety profile of all participants in each age group and each study intervention... expand

The primary objectives of the study are: - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. - To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The secondary objectives of the study are: - To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group. - To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group. - To describe the occurrence of virologically-confirmed COVID-19-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. - To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Type: Interventional

Start Date: Sep 2020

open study

Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
Sorrento Therapeutics, Inc. Covid19
This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings... expand

This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.

Type: Interventional

Start Date: Dec 2020

open study

DISulfiram for COvid-19 (DISCO) Trial
University of California, San Francisco Covid19
Disulfiram (DSF) a safe, easily dosed, FDA-approved drug for the treatment of alcohol dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection. Disulfiram may have both antiviral (inhibiting viral replication via blocking the Mpro protease... expand

Disulfiram (DSF) a safe, easily dosed, FDA-approved drug for the treatment of alcohol dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection. Disulfiram may have both antiviral (inhibiting viral replication via blocking the Mpro protease and zinc ejection) and anti-inflammatory effects (via inhibition of NF-kB-induced and NLRP inflammasome-induced cytokine release) on SARS-CoV-2. We will study oral disulfiram given for 5 consecutive days (1000 mg/day in cohort 1; 2000 mg/day in cohort 2) in 60 symptomatic COVID+ individuals in a randomized (2:1) randomized, double blind placebo-controlled trial evaluating disulfiram's effect on COVID-19 symptom severity, SARS-CoV-2 viral load, and biomarkers of inflammation and pyroptosis (aberrant pro-inflammatory cell death) over 31 days.

Type: Interventional

Start Date: Dec 2020

open study

University of Utah COVID-19 Hydrochloroquine Trial
University of Utah Coronavirus Infection Coronavirus Infectious Disease
A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19,... expand

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

Type: Interventional

Start Date: Apr 2020

open study

Study of Sargramostim in Patients With COVID-19
Partner Therapeutics, Inc. COVID-19 Sars-CoV2
The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from the effects of COVID-19, and this research study will help to find this out. expand

The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from the effects of COVID-19, and this research study will help to find this out.

Type: Interventional

Start Date: Aug 2020

open study

Immune Modulators for Treating COVID-19
Daniel Benjamin Covid19
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with... expand

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.

Type: Interventional

Start Date: Oct 2020

open study

Use of Remote Monitoring for COVID-19 Patient
Montefiore Medical Center COVID
The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration,... expand

The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

Type: Interventional

Start Date: Sep 2020

open study

ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
University of Utah Hypertension COVID
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, enters type II pneumocytes using angiotensin-converting enzyme 2 (ACE2). It is unclear whether ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) increase, decrease,... expand

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, enters type II pneumocytes using angiotensin-converting enzyme 2 (ACE2). It is unclear whether ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) increase, decrease, or have no significant effect on ACE2 expression or activity. Therefore, ACEI and ARB may be harmful, beneficial, or have no impact on Coronavirus Disease 2019 severity and mortality. The Specific Aims of this observational study are: (1) Among SARS-CoV-2-positive outpatients, compare all-cause hospitalization and mortality rates between: 1.1 Current users of a range of doses of ACEI/ARB- vs. non- ACEI/ARB-based regimens, and 1.2 Current users of a range of doses of ACEI- vs. ARB-based regimens, and (2) Among those hospitalized for COVID-19, compare all-cause mortality between: 2.1 Current users of a range of doses of ACEI/ARB- vs. non- ACEI/ARB-based regimens, and 2.2 Current users of a range of doses of ACEI- vs. ARB-based regimens.

Type: Observational

Start Date: Jan 2020

open study

Anti-SARS Cov-2 T Cell Infusions for COVID 19
Baylor College of Medicine SARS-CoV 2 Viral Infection COVID 19
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The... expand

This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.

Type: Interventional

Start Date: Nov 2020

open study

SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE...
Virginia Commonwealth University COVID-19 Lung Injury, Acute Kidney Injury
This study will the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19. expand

This study will the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19.

Type: Interventional

Start Date: Jan 2021

open study

Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS
Queen's Medical Centre COVID-19
The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching... expand

The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.

Type: Interventional

Start Date: Jun 2020

open study

Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Memorial Sloan Kettering Cancer Center COVID-19
The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection. expand

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.

Type: Interventional

Start Date: May 2020

open study

Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment...
Regeneron Pharmaceuticals COVID-19
The primary objectives are: 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 shedding of SARS-CoV-2... expand

The primary objectives are: 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 shedding of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2 Phase 3 • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo

Type: Interventional

Start Date: Jun 2020

open study

Vitamin D and COVID-19 Trial
Brigham and Women's Hospital COVID-19
The Vitamin D and COVID-19 Trial (VIVID) is a nationwide randomized clinical trial in 2700 U.S. men and women to investigate whether taking a daily dietary supplement of vitamin D for 4 weeks reduces the risk of hospitalization and/or death in participants newly diagnosed with... expand

The Vitamin D and COVID-19 Trial (VIVID) is a nationwide randomized clinical trial in 2700 U.S. men and women to investigate whether taking a daily dietary supplement of vitamin D for 4 weeks reduces the risk of hospitalization and/or death in participants newly diagnosed with COVID-19, and reduces the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in their closest household contacts (as documented by seroconversion).

Type: Interventional

Start Date: Dec 2020

open study

Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19
Sorrento Therapeutics, Inc. Covid-19
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19 expand

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

Type: Interventional

Start Date: Oct 2020

open study

Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients
Stanford University Covid19
The primary objective is to evaluate the safety and efficacy of intravenous (IV) infusion of Ang (1-7) compared to placebo with respect to time to recovery, disease severity, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and mortality in patients... expand

The primary objective is to evaluate the safety and efficacy of intravenous (IV) infusion of Ang (1-7) compared to placebo with respect to time to recovery, disease severity, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and mortality in patients with COVID 19.

Type: Interventional

Start Date: Jan 2021

open study

ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
Boehringer Ingelheim COVID-19
This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition. The purpose of the study is to find out whether a medicine called... expand

This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition. The purpose of the study is to find out whether a medicine called BI 764198 helps people with COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with COVID-19 infection. Participants are put into 2 groups by chance. One group of participants gets BI 764198 capsules and the other group gets placebo capsules. The placebo capsules look exactly like the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day. Participants are in the study for about a month. At study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. During the study, the doctors collect information on any health problems of the participants.

Type: Interventional

Start Date: Nov 2020

open study

COVID-19 Convalescent Plasma
University of Chicago Coronavirus
The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19),... expand

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

Type: Interventional

Start Date: Apr 2020

open study

Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
Indiana University SARS-CoV-2 Serology Students
The primary goal for this study is to assess whether receiving the results of an antibody test changes protective behavior to avoid SARS-CoV-2 infections (i.e., mask-wearing, physical distancing, limiting close contacts/avoiding crowds, hand-washing, avoiding contact with... expand

The primary goal for this study is to assess whether receiving the results of an antibody test changes protective behavior to avoid SARS-CoV-2 infections (i.e., mask-wearing, physical distancing, limiting close contacts/avoiding crowds, hand-washing, avoiding contact with high-risk individuals). While studies have been published on the cross-sectional relationship between risk perception and other demographic characteristics and health behaviors that are protective for SARS-CoV-2 infection (see citations), there have been no studies showing the effect of receiving information about antibody positivity on protective behavior. Not only can results from this study be used to better model transmission, a better understanding of college student's risk perception around SARS-CoV-2 infections has implications for future vaccination strategies as well. There are concerns that a desire to return to "normal" life in combination with reduced perception of risk could have negative consequences for uptake of vaccination (Johns Hopkins Center for Health Security 2020 report, The Public's Role in COVID-19 Vaccination: Planning Recommendations Informed by Design Thinking and the Social, Behavioral, and Communication Sciences). The antibody test used in this study is named 'SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold)'. It provides a fast, on-site, and accurate detection of IgM/IgG antibodies against SARS-CoV-2, with positive results of IgM antibodies indicating a recent infection, while positive results of IgG antibodies signaling a longer or previous infection. It can detect IgM and IgG antibodies against SARS-CoV-2 in human specimens of serum, plasma, or venous whole blood.

Type: Interventional

Start Date: Sep 2020

open study

COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Neuroganics LLC Communicable Disease COVID-19 Sars-CoV2 Infectious Disease Coronavirus
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic tests, like Coris Bioconcept Ag Respi-strip COVID-19 test, and LAMP-based molecular tests) in order to judge their clinical accuracy compared to Centers for Disease Control... expand

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic tests, like Coris Bioconcept Ag Respi-strip COVID-19 test, and LAMP-based molecular tests) in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support.

Type: Interventional

Start Date: Apr 2020

open study

Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus...
CytoDyn, Inc. Coronavirus Disease 2019
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease. expand

The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

Type: Interventional

Start Date: Apr 2020

open study

Long-term Impact of Infection With Novel Coronavirus (COVID-19)
University of California, San Francisco COVID
LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC... expand

LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.

Type: Observational

Start Date: Apr 2020

open study

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults
Janssen Vaccines & Prevention B.V. Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
The study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participants. expand

The study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participants.

Type: Interventional

Start Date: Nov 2020

open study