COVID-19 Clinical Trials

Principal Investigator: Dr. Monica McAuther

Study Objectives:

A Vaccine Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants

Study Design:

Target Population:

Adults, 18 Years of Age or older.

ClinicalTrials.gov Identifier:  NCT04368988 

Principal Investigator: Dr. Karen Kotloff

Study Objectives:

A Vaccine Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

Study Design:

Target Population:

Adults, 18 Years of Age or older.

ClinicalTrials.gov Identifier:  NCT04470427 

Principal Investigator: Dr. James Campbell

Study Objectives:

A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age.

Study Design:

Target Population:

Children 6 Months to Less Than 12 Years of Age.

ClinicalTrials.gov Identifier:  NCT04796896 

Center for Vaccine Development and Global Health (CVD) Clinical Trials

Principal Investigator: Dr. Rohit Talwani

Study Objectives:

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

Study Design:

Target Population:

Adults; 18 yrs and older, all sexes (non-pregnant women).

ClinicalTrials.gov Identifier:  NCT04505722 

Principal Investigator: Dr. Kathleen Nuezil

Study Participants Needed for COVID-19 Vaccine

The University of Maryland School of Medicine is seeking participants 18 and older for an investigational COVID-19 Vaccine. You may qualify for this study even if you have underlying health conditions. Compensation up to $1,620 is provided.

To volunteer:

• Call: 410-706-6156 (8 am - 4 pm)
• Email: clintrial@som.umaryland.edu
• Complete our Online Contact Form  (en español)

Principal Investigator: Dr. Kathleen Nuezil

Do you live in the home with someone who was recently diagnosed with COVID-19 infection?

If so, you may qualify for a research study of an experimental COVID-19 preventative therapy.

Principal Investigator: Dr. Joel Chua

Study Objectives:

Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2.

Study Design:

Target Population:

Asymptomatic Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to <18 years of age, or pediatric participants <12 years of age at the signing of the assent (parent/guardian sign the informed consent)

ClinicalTrials.gov Identifier:  NCT04452318 

Principal Investigator: Dr. Christine Lau

Study Objectives:

A Randomized, Parallel Assignment Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Regadenoson for Moderate to Severe COVID-19 Adult Patients.

Study Design:

Target Population:

Adult, laboratory confirmed by polymerase chain reaction (PCR), Moderate to Severe COVID-19 patients.

ClinicalTrials.gov Identifier:  NCT04606069 

Principal Investigator: Dr. Shivakumar Narayanan

Study Objectives:

The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.

Study Design:

Target Population:

Adult Non-Hospitalized, SARS-CoV-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening

ClinicalTrials.gov Identifier:  NCT04501952 

Principal Investigator: Dr. Carl Shanholtz

Study Objectives:

The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting.

Study Design:

Target Population:

Adult Ambulatory patients with SARS-CoV-2 (COVID-19).

ClinicalTrials.gov Identifier:  NCT04362176 

Principal Investigator: Dr. Ronson Madathil

Study Objectives:

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

Study Design:

Target Population:

Adult Ambulatory patients with SARS-CoV-2 (COVID-19).

ClinicalTrials.gov Identifier:  NCT04501978 

Principal Investigator: Dr. Gentry Wilkerson

Study Objectives:

This study will assess the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19. 

Study Design:

Target Population:

Adult Ambulatory patients with SARS-CoV-2 (COVID-19).

ClinicalTrials.gov Identifier:  NCT04425629 

Principal Investigator: Dr. Shivakumar Narayanan

Study Objectives:

This study will assess the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19. 

Study Design:

Target Population:

Adult hospitalized patients with SARS-CoV-2 (COVID-19).

ClinicalTrials.gov Identifier:  NCT04426695 

Principal Investigator: Dr. Joseph Rabin

Study Objectives:

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. 

Study Design:

Target Population:

Adult hospitalized patients with SARS-CoV-2 (COVID-19) pneumonia .

ClinicalTrials.gov Identifier: NCT04409262

Principal Investigator: Dr. John Baddley

Study Objectives:

A Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

Study Design:

Target Population:

Adult hospitalized Immunocompromised patients with diagnosed SARS-CoV-2 and Lower Respiratory Tract Parainfluenza Infection. 

ClinicalTrials.gov Identifier:  NCT03808922

Principal Investigator: Dr. Jacqueline Bork

Study Objectives:

To evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome compared with Best supportive care in adults hospitalized with COVID-19.

Study Design:

Target Population:

Adult hospitalized patients with diagnosed SARS-CoV-2 with severe pneumonia, acute lung injury, or acute respiratory distress syndrome. 

ClinicalTrials.gov Identifier:  NCT04369469

Principal Investigator: Dr. Kousick Biswas

Purpose:

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.

Study Design:

This is a randomized phase 2, placebo-controlled, double blind clinical trial to compare the efficacy of degarelix + BSC to the placebo + BSC on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Patients will be centrally randomized 2:1 (degarelix + BSC: placebo + BSC) to the study arms. BSC consists of supplemental oxygen, antibiotics, vasopressor support, peritoneal or hemodialysis, antibiotics, intravenous fluids, etc.

Participant Population:

Adult Male Veterans admitted to a VA hospital, Hospitalized on an acute care ward due to COVID-19.

ClinicalTrials.gov Identifier:  NCT04397718

Principal Investigator: Dr. Ashkan Emadi

Study Objectives:

To evaluate the efficacy, safety, and tolerability of combination of imatinib compared with placebo in combination with the BCC in adults hospitalized with COVID-19.

Study Design:

Target Population:

Adult hospitalized patients with Positive RT-PCR assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or BAL) by Center for Disease Control or local laboratory within 7 days of randomization. 

ClinicalTrials.gov Identifier:  NCT04394416

Principal Investigator: Dr. Magali Fontaine

Study Objectives:

Study Design:

This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following registration on the protocol and provision of informed consent, patients will be transfused with one unit of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. 

Target Population:

ClinicalTrials.gov Identifier: NCT04338360

Principal Investigator: Dr. Rohit Talwani

Study Objectives:

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

Study Design:

This is an expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

Target Population:

12 years and older hospitalized patients with confirmed SARS-CoV2 requiring invasive mechanical ventilation.

ClinicalTrials.gov Identifier: NCT04323761

Principal Investigator: Dr. Rohit Talwani

Study Objectives:

This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.

Study Design:

A Phase 1b/2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19).

Target Population:

Adult hospitalized patients ≥60 years old with underlying medical comorbidities OR Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; OR (ii) Requiring non-invasive or invasive mechanical ventilation..

ClinicalTrials.gov Identifier: NCT04341116

Principal Investigator: Dr. Joseph Rabin

Study Objectives:

The primary objective is to evaluate the pharmacodynamics, pharmacokinetics, safety, and efficacy of tocilizumab (TCZ) at two different doses in combination with standard-of-care (SOC) treatment in hospitalized patients with moderate to severe COVID-19 pneumonia. .

Study Design:

Target Population:

Adult hospitalized patients with SARS-CoV-2 (COVID-19) pneumonia .

ClinicalTrials.gov Identifier: NCT04320615

Principal Investigator: Dr. Joel Chua

Study Objectives:

The primary objective is to evaluate the efficacy and safety of hydroxychloroquine monotherapy and in combination with azithromycin plus standard of care compared to placebo plus standard of care in patients with Severe Acute Respiratory Syndrome Coronavirus (SAR-CoV)-2 infection.

Study Design:

Target Population:

Adult hospitalized patients with Severe Acute Respiratory Syndrome Coronavirus (SAR-CoV)-2 infection.

ClinicalTrials.gov Identifier:  NCT04358081

Principal Investigator: Dr. Joel Chua

Study Objectives:

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in adult patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).

Study Design:

Patients who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio to either canakinumab + SOC or placebo + SOC and can be dosed immediately after ensuring that the patient has met all eligibility criteria. Patients in the canakinumab arm will be dosed on Day 1 with canakinumab 450 mg for body weight of 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Patients in the placebo arm will be administered with 250 mL of 5% dextrose infused IV over 2 hours.

Target Population:

Adult patients Clinically diagnosed with SARS-CoV-2 virus, Hospitalized with COVID-19-induced pneumonia.

ClinicalTrials.gov Identifier: NCT04362813

Principal Investigator: Dr. Sunjay Kaushal

Study Objectives:

The primary objective is to evaluate the efficacy and safety of mesenchymal stromal cell (MSC) remestemcel-L ® plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to COVID19.

Study Design:

This will be a randomized (1:1 ratio), double blind, parallel design placebo controlled trial. Randomization will be stratified by clinical center and by moderate versus severe ARDS. The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients have reached the primary endpoint using Bayesian predictive probabilities.

Target Population:

Adult patients with moderate to severe ARDS due to COVID-19.

ClinicalTrials.gov Identifier: NCT04371393

Principal Investigator: Dr. Shyamasundaran Kattilil

Study Design: 

The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19.

Arm A: CD24Fc/Best Available Treatment

Arm B: placebo/ Best Available Treatment

CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

Posted on ClinicalTrials.gov as NCT04317040

Clinical trials by Organization

• COVID-19 clinical trials from ClinicalTrials.gov
• Clinical trial registries worldwide from HHS.gov

Clinical trials by location

• United States
• Maryland

Clinical trials by drug

• Colchicine
• Hydroxychloroquine
• Remdesevir
• Kaletra (Lopinavir/Ritonavir)
• Tocilizumab