1,339 matching studies

Sponsor Condition of Interest
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against...
Sanofi Pasteur, a Sanofi Company COVID-19 (Healthy Volunteers)
The primary objectives of the study are: - To assess the safety profile of the study vaccines in each study intervention group. - To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. - To demonstrate... expand

The primary objectives of the study are: - To assess the safety profile of the study vaccines in each study intervention group. - To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. - To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a two-dose priming series with the monovalent vaccine, and superior to that observed immediately before booster. - To demonstrate that two doses of monovalent (B.1.351)-AS03 or bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine induce an immune response that is non inferior to the response induced by monovalent (D614)-AS03 vaccine. The secondary objectives of the study are: - To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. - To assess the neutralizing and binding antibody responses of booster vaccination. - To describe the occurrences of laboratory-confirmed symptomatic COVID-19 after primary series and booster vaccination. - To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

Type: Interventional

Start Date: Feb 2021

open study

Study of Varespladib in Patients Hospitalized With Severe COVID-19
Ophirex, Inc. Coronavirus Disease 2019 Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition to standard of care, in patients hospitalized with severe COVID-19 caused by SARS-CoV-2. expand

This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition to standard of care, in patients hospitalized with severe COVID-19 caused by SARS-CoV-2.

Type: Interventional

Start Date: Jun 2021

open study

Pilot Study for Simultaneous PET-MR Imaging of Covid-19 Associated Neurological Complications Using a...
Stanford University Brain Diseases Covid19
The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a... expand

The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a pilot study for establishing an imaging protocol for combined PET and MR derived functional information as well as MRI acquired anatomical information.

Type: Interventional

Start Date: Sep 2021

open study

COVID-19 Vaccinations With a Sweepstakes
University of Pennsylvania Covid19
To reach herd immunity for COVID-19, experts estimate that 70% of the population will need to be vaccinated. However, vaccination rates have begun to slow down in the United States. The investigators will partner with Philadelphia to launch a COVID-19 vaccination sweepstakes, in... expand

To reach herd immunity for COVID-19, experts estimate that 70% of the population will need to be vaccinated. However, vaccination rates have begun to slow down in the United States. The investigators will partner with Philadelphia to launch a COVID-19 vaccination sweepstakes, in which residents will be eligible to win if they have received at least one dose of the COVID-19 vaccine prior to a given drawing. Drawings will be held every two weeks; multiple prizes of various sizes will be awarded in each drawing. Half of the prizes in each size category in each drawing will be awarded to residents of a zip code that is randomly selected from a pre-defined list of under-vaccinated zip codes (this zip code will be announced at the start of each 2-week drawing period), the other half will be awarded to residents outside of that selected zip code. The investigators will analyze vaccination rates in Philadelphia as compared with neighboring regions before, during, and after the specified time period, as well as analyze vaccination rates in the three selected zip codes compared to the other zip codes that could have been targeted (the residual set of under-vaccinated zip codes) to determine the effectiveness of the sweepstakes at encouraging vaccinations.

Type: Interventional

Start Date: Jun 2021

open study

Chinese Herbal Formula for COVID-19
University of California, San Diego Covid19
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management.... expand

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.

Type: Interventional

Start Date: Jul 2021

open study

Novel Experimental COVID-19 Therapies Affecting Host Response
Vanderbilt University Medical Center COVID-19 SARS-CoV-2 Infection Coronavirus Infection
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure,... expand

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

Type: Interventional

Start Date: Jul 2021

open study

Antithrombin III in Infectious Disease Caused by COVID-19
Enrique Ginzburg Antithrombin III Deficiency Covid19
The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3. expand

The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3.

Type: Interventional

Start Date: Jul 2021

open study

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated...
Novartis Pharmaceuticals Relapsing Multiple Sclerosis (RMS)
This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly can develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate. expand

This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly can develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.

Type: Interventional

Start Date: Jun 2021

open study

Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Washington University School of Medicine Covid19
The primary goal of this study is to determine the most effective SARS-CoV-2 testing strategy for successful return of in-person school in the under-served communities of St. Louis. Regular screening testing has been recommended by the CDC as an additive mitigation strategy... expand

The primary goal of this study is to determine the most effective SARS-CoV-2 testing strategy for successful return of in-person school in the under-served communities of St. Louis. Regular screening testing has been recommended by the CDC as an additive mitigation strategy for in-person schools in areas of high community transmission. We will compare the effectiveness and acceptance of two different school-based testing strategies among students and school staff (symptomatic testing only versus weekly surveillance testing plus symptomatic testing), measuring school-based SARS-CoV-2 transmission through a cluster randomized trial.

Type: Interventional

Start Date: May 2021

open study

Estradiol and Progesterone in Hospitalized COVID-19 Patients
Tulane University Covid19
The purpose of this study is to determine to what extent a short systemic steroid therapy with estradiol and progesterone, administered early to hospitalized and confirmed COVID-19 positive patients of both sexes in addition to standard of care (SOC) can reduce the severity... expand

The purpose of this study is to determine to what extent a short systemic steroid therapy with estradiol and progesterone, administered early to hospitalized and confirmed COVID-19 positive patients of both sexes in addition to standard of care (SOC) can reduce the severity of symptoms and outcomes compared to SOC alone.

Type: Interventional

Start Date: Jul 2021

open study

Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
AzurRx BioPharma, Inc. Covid19
This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection. expand

This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.

Type: Interventional

Start Date: Apr 2021

open study

The Effect of a Combined Nature-based and Virtual Mindfulness Intervention on Perceived Stress in Healthcare...
National Institutes of Health Clinical Center (CC) Stress, Psychological Sleep Disturbance Burnout, Caregiver Posttraumatic Stress Disorder Anxiety
Rationale: Healthcare workers that care for patients with COVID-19 are at increased risk for stress-related symptoms. When these symptoms are chronic, they can result in burnout and other mental health conditions that can exacerbate the current national health crisis. Social... expand

Rationale: Healthcare workers that care for patients with COVID-19 are at increased risk for stress-related symptoms. When these symptoms are chronic, they can result in burnout and other mental health conditions that can exacerbate the current national health crisis. Social distancing can limit the accessibility of mental health services. Feasible and effective interventions are needed to reduce stress-related symptoms and promote resilience in this population, while adhering to federal and local guidelines to mitigate the transmission of SARS-CoV-2. Objectives: To investigate the feasibility and efficacy of a combined nature-based and virtual mindfulness intervention on stress-related symptoms and psychological resilience in healthcare workers that care for patients with COVID-19. Both components are reported to reduce levels of perceived stress and increase psychological resilience; however, the potential additive effect of their combined delivery is unknown. Methods: Ninety healthcare workers will be randomized into one of three groups: Nature+Mindfulness (n=30), Nature only (n=30), and Control (n=30). All participants will undergo assessments at baseline (week 0), post nature intervention (~week 1), and post mindfulness intervention (~week 3). The two intervention groups will have one final assessment at 2-month follow-up (~week 11). Perceived stress is the primary endpoint and will be assessed with the Perceived Stress Scale. Secondary endpoints include sleep quality, burnout, posttraumatic stress, anxiety, depression, mindfulness, self-efficacy, and psycho-social-spiritual healing. Anticipated Results: We anticipate that participants in the Nature+Mindfulness group will have greater reductions in stress-related symptoms and greater increases in psychological resilience compared with the Nature only and Control groups.

Type: Interventional

Start Date: Jun 2021

open study

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
National Institute of Allergy and Infectious Diseases (NIAID) Covid19
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of... expand

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Type: Interventional

Start Date: Apr 2021

open study

VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients...
Veru Inc. SARS-CoV Infection
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60). expand

To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).

Type: Interventional

Start Date: May 2021

open study

Dual MRI for Cardiopulmonary COVID-19 Long Haulers
Bastiaan Driehuys Covid19
The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting... expand

The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting that recovered patients have significant residual pulmonary disease, while myocardial injury has also been increasingly reported. To optimally care for these patients, Duke Pulmonary study team must comprehensively assess and monitor the changes in cardiopulmonary function and relate the changes to physiologic and quality of life outcomes. The study team will deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30 subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later. Cardiac MRI will assess the myocardial status and right ventricular function, while hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging characterization of cardiopulmonary structure and function in patients recovered from Covid-19.

Type: Interventional

Start Date: May 2021

open study

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19...
BioNTech SE SARS-CoV-2 Infection, COVID-19
This is a Phase 1/2/3 study in healthy children <12 years of age. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants... expand

This is a Phase 1/2/3 study in healthy children <12 years of age. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

Type: Interventional

Start Date: Mar 2021

open study

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19...
National Institute of Allergy and Infectious Diseases (NIAID) SARS-CoV-2 Infection
The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine. expand

The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine.

Type: Interventional

Start Date: Mar 2021

open study

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between...
ModernaTX, Inc. SARS-CoV-2
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart. expand

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart.

Type: Interventional

Start Date: Mar 2021

open study

Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19...
Thomas Jefferson University Covid19
This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced... expand

This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced age, or other underlying health conditions. The outcomes of patients receiving the T cells (Arm A) will be compared to patients treated with standard of care (Arm B).

Type: Interventional

Start Date: Jul 2021

open study

COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
National Institute of Allergy and Infectious Diseases (NIAID) SARS-CoV Infection COVID-19 Allergic Reaction Mast Cell Disorder
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have... expand

Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: - To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and - If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders

Type: Interventional

Start Date: Apr 2021

open study

COVID Breath Test - Ancon
Medical University of South Carolina Covid19
This study is designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath... expand

This study is designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.

Type: Observational

Start Date: Dec 2020

open study

Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease
RedHill Biopharma Limited Covid19
A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care. expand

A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.

Type: Interventional

Start Date: Feb 2021

open study

Sargramostim Use in COVID-19 to Recover Patient Health
Partner Therapeutics, Inc. Covid19 SARS-CoV Infection
The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits... expand

The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization, or death.

Type: Interventional

Start Date: Apr 2021

open study

Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients...
University of Michigan Covid19 Kidney Diseases Inflammation SARS-CoV Infection
To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the University of... expand

To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the University of Michigan. The purpose of M2C2 is to define the in-hospital course of these patients and understand the role of inflammation as a determinant of organ injury and outcomes in COVID-19.

Type: Observational

Start Date: Mar 2020

open study

A Real World Study of Bamlanivimab in Participants With Mild-to-moderate Coronavirus Disease 2019 (COVID-19)
Eli Lilly and Company COVID-19
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who... expand

The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.

Type: Interventional

Start Date: Feb 2021

open study