COVID-19 Clinical Trials

Researchers across a wide variety of disciplines at University of Maryland Baltimore and the University of Maryland Medical System are using their expertise to address the COVID-19 pandemic. They are conducting a number of clinical trials that are currently enrolling participants. Learn more about each clinical trial below.


 

Experimental COVID-19 Vaccine Trial (Recruitment Status Open)
The study will evaluate the safety of a potential vaccine and its ability to generate an immune response against COVID-19.

Link to Trial Page

Principal Investigator: Dr. Kathleen Nuezil

Study Participants Needed for an Experimental COVID-19 Vaccine

Healthy adults aged 18 to 85 years old are needed to participate in the study of an investigational COVID-19 vaccine. The study will evaluate the safety of the vaccine and its ability to generate an immune response against COVID-19. Financial compensation up to $1,375 for qualified participants.

Ready to get started?

To volunteer:

Experimental COVID-19 Prevention Trial (Recruitment Status Open)
Study the effectiveness of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Infection Among Adults Exposed to Coronavirus Disease (COVID-19).

Link to Trial Page

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.

Learn more at www.covid19pepstudy.org

Phase 3 Study: CD24Fc in COVID-19 Treatment (Enrollment by Invitation)
A Phase 3 Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment. This study is for patients in the hospital being treated for severe COVID-19.

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

Mesenchymal Stem Cells in COVID-19 Treatment (Enrollment by Invitation)
Mesenchymal Stem Cells for the treatment of moderate to severe COVID-19 Acute Respiratory Distress Syndrome. This study is for patients in the hospital being treated for moderate to severe COVID-19.

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

Phase 3 Study: Canakinumab in COVID-19 Pneumonia Treatment (Enrollment by Invitation)
Phase 3 multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab on cytokine release syndrome in patients with COVID-19-induced pneumonia. This study is for patients in the hospital being treated for severe COVID-19.

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

Study: Hydroxychloroquine and Azithromycin in COVID-19 Treatment (Enrollment by Invitation)
A multi-center study to evaluate the safety and efficacy of hydroxychloroquine monotherapy and in combination with azithromycin in patients with moderate and severe COVID-19 disease. This study is for patients in the hospital being treated for severe COVID-19.

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:

This study is a multi-center, randomized, blinded, three-arm parallel-group, placebo-controlled trial to evaluate the safety and efficacy of hydroxychloroquine monotherapy or in combination with azithromycin in participants with moderate and severe COVID-19 disease excluding critically ill participants (i.e. those needing ICU admission or mechanical ventilation at study start).

The study will include: Screening period of up to four days to obtain the informed consent and assess participant’s eligibility; Treatment period of 10 days; and an observation period of an additional 30 days (until Day 40) with Day 40 being the end of study visit.

Target Population:

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

ClinicalTrials.gov Identifier:  NCT04358081

Phase 2 Study: Tocilizumab in COVID-19 Pneumonia Treatment (Enrollment by Invitation)
This Phase II study will investigate 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. This study is for patients in the hospital being treated for severe COVID-19.

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:

This study is a multi-center, randomized trial to evaluate the pharmacodynamics, pharmacokinetics, safety, and efficacy of tocilizumab (TCZ) at two different doses. Patients will be randomized as soon as possible after screening in a 1:1 ratio to receive treatment with either 8 mg/kg or 4 mg/kg IV TCZ. Study treatment must be given in combination with Standard of Care treatment. 

Target Population:

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

ClinicalTrials.gov Identifier: NCT04320615

Adaptive COVID-19 Treatment Trial (Enrollment by Invitation)
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults.

Principal Investigator: Dr. James Campbell

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). 

ClinicalTrials.gov Identifier: NCT04280705

Phase 1/2 Study: TJ003234 in COVID-19 Treatment (Enrollment by Invitation)
This Phase I/II study will 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. This study is for Hospitalized patients ≥60 years old with underlying medical comorbidities.

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

Expanded Access Program for remdesivir for COVID19 patients (Enrollment by Invitation)
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. This study is for 12 years and older hospitalized patients with confirmed SARS-CoV2 requiring invasive mechanical ventilation.

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

Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19 (Enrollment by Invitation)
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.

Principal Investigator: Dr. Magali Fontaine

Study Objectives:

Provide access to COVID-19 convalescent plasma

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:

Acute care facilities treating patients with COVID-19 and with severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations

ClinicalTrials.gov Identifier: NCT04338360

Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects (Enrollment by Invitation)
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects with Recently Diagnosed COVID-19 Compared to Standard of Care Treatment

Principal Investigator: Dr. Gentry Wilkerson
 
Study Description:
BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9 that is selective over the cathepsins as well as other protease families, displays good metabolic stability and permeability, oral bioavailability and low cytochrome P450 (CYP) inhibition. It is under development for the treatment of coronavirus disease-19 (COVID-19) resulting from infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV2), where there is significant unmet medical need.
 
Study Design:
Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects With Recently Diagnosed COVID-19 Compared to Standard of Care Treatment.
 
Target Population:
Adult patients hospitalized for COVID-19.
 
ClinicalTrials.gov Identifier: NCT04334460

 

Phase 3 Study: Imatinib in COVID-19 Treatment (Enrollment by Invitation)
This study is a randomized, double-blind, placebo controlled trial to evaluate the safety and effectiveness of an existing medication called imatinib in hospitalized adults diagnosed with Novel Coronavirus COVID-19.

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:

This is an individual patient-level randomized, double-blind, placebo-controlled phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from start of study drug administration. Eligible patients will be randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the best conventional care.

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

Phase 2 Study: Baltimore VA, Degarelix in COVID-19 Treatment (Enrollment by Invitation)
This Baltimore Veterans Affairs Medical Center study is to determine if temporary androgen suppression induced by degarelix improves the clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.

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

Phase 3 Study: Ravulizumab in COVID-19 Treatment (Enrollment by Invitation)
This study will 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 in hospitalized adults.

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:

A Phase 3 Open-label, Randomized, Controlled Study. 

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

Phase 3 Study: DAS181 in COVID-19 Treatment (Enrollment by Invitation)
A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of in Immunocompromised hospitalized adult Subjects.

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:

A Phase III Randomized Placebo-Controlled Study. 

Target Population:

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

ClinicalTrials.gov Identifier:  NCT03808922

Phase 3 Study: Remdesivir plus Tocilizumab in COVID-19 Pneumonia Treatment (Enrollment by Invitation)
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.

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:

A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia.

Target Population:

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

ClinicalTrials.gov Identifier: NCT04409262

COVID-19 Clinical Trials Around the World
Search for all COVID-19 Trials through clinicaltrials.gov and HHS.