CORONAVIRUS DISEASE 2019
ACTIVE THERAPEUTIC COVID-19 CLINICAL RESEARCH STUDIES
To provide the most advanced care to our patients, the Brigham is enrolling eligible, admitted patients with COVID-19 in clinical trials of new therapeutics. The Brigham has several clinical trials that are underway, and more that will begin enrollment in the near future. The following list will be updated as new clinical research studies begin.
Protocol Number: 2020P002674
PI: Baden, Lindsey R
Title: 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 (VAC31518)
Intervention: Anti-Spike SARS-CoV-2 Monoclonal Antibodies
Subject Population: Outpatient/Clinical Trials Center
Site: BWH
Status: Active, Enrolling
Protocol Number: 2020P001953
PI: Baden, Lindsey R
Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (Moderna- mRNA-1273-P301)
Intervention: mRNA-1273 SARS-CoV-2 Vaccine
Subject Population: Outpatient
Site: BWH
Status: Active, Enrolling
Protocol Number: 2020P001888
PI: Bhasin, Shalender
Title: A Phase 2a Randomized Controlled Trial of MIB-626 (ß Nicotinamide Mononucleotide, NMN) vs. Placebo in Adults with COVID-19 Infection and Early Acute Kidney Injury
Intervention: Nicotinamide Mononucleotide
Subject Population: Offsite
Site: BWH
Status: Active, Enrolling
Protocol Number: 2020P002725
PI: Boyer, Edward W
Title: A Phase 2/3, 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)
Intervention: TJ003234
Subject Population: Emergency Department, Inpatient, Clinical Trials Center
Site: BWH
Status: Active, Enrolling
NCT: NCT04341116
Protocol Number: 2020P001316
PI: Frendl, George
Title: A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive
Intervention: Ravulizumab
Subject Population: Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04369469
Protocol Number: 2020P001641
PI: Hou, Peter C
Title: A Phase 2, randomized, placebo-controlled, participant and investigator blinded, multi-center study to assess efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function
Intervention: MAS825
Subject Population: Emergency Department, Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04382651
Protocol Number: 2021P000977
PI: Hou, Peter
Title: A Phase II Multi-Center, Double-Blind, Randomized and Placebo-Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a for the Treatment of Hospitalized Patients with COVID-19 Infection
Intervention: Early intravenous (IV) IFN beta-1a administration
Subject Population: Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04860518
Protocol Number: 2020P001092
PI: Hou, Peter C
Title: Mesenchymal Stem Cells For the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress
Intervention: Mesenchymal Stem Cells
Subject Population: Emergency Department, Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04371393
Protocol Number: 2020P001040
PI: Hou, Peter
Title: Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID)
Intervention: Hydroxychloroquine
Subject Population: Hydroxychloroquine treatment for admitted patients with COVID-19
Site: BWH
Status: Active, Enrolling
NCT: NCT04332991
Protocol Number: 2021P000496
PI: Hou, Peter C
Title: Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM)
Intervention: Aspirin and apixaban
Subject Population: Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04593940
Protocol Number: 2020P001286
PI: Kuritzkes, Daniel R
Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects with Moderate COVID-19
Intervention: AT-527
Subject Population: Emergency Department, Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04396106
Protocol Number: 2020P001120
PI: Kuritzkes, Daniel
Title: 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 (CAN-COVID)
Intervention: Canakinumab
Subject Population: Emergency Department, Inpatient, Outpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT04362813
Protocol Number: 2020P001978
PI: Manne-Goehler, Jennifer
Title: A MASTER PROTOCOL ASSESSING THE SAFETY, TOLERABILITY, AND EFFICACY OF ANTI-SPIKE (S) SARS-COV-2 MONOCLONAL ANTIBODIES FOR THE TREATMENT OF HOSPITALIZED PATIENTS WITH COVID-19
Intervention: Anti-Spike SARS-CoV-2 Monoclonal Antibodies
Subject Population: Inpatient
Site: BWH
Status: Active, Enrolling
NCT: NCT0446695
Protocol Number: 2020P002089
PI: Marty, Francisco
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study 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
Intervention: Anti-Spike SARS-CoV-2 Monoclonal Antibodies
Subject Population: Outpatient/Clinical Trials Center
Site: BWH
Status: Active, Enrolling
Protocol Number: 2020P002356
PI: Piazza, Gregory
Title: A multicenter, randomized, placebo-controlled, pragmatic Phase 3 study investigating the efficacy and safety of rivaroxaban to reduce the risk of major venous and arterial thrombotic events, hospitalization and death in medically ill outpatients with acute, symptomatic COVID-19 infection PREVENT-HD
Intervention: Rivaroxaban
Subject Population: Outpatient/Main Hospital
Site: BWH
Status: Active, Enrolling
Protocol Number: 2020P000799
PI: Walsh, Stephen R
Title: 6R88-COV-2040 An Adaptive Phase 2/3, Randomized, double-blind, placebo-controlled study assessing efficacy and safety of Sarilumab for hospitalized patients with COVID-19
Intervention: Sarilumab
Subject Population: Emergency Dept and Inpatients
Site: BWH, MGH
Status: Active, Closed Enrollment
NCT: NCT04315298
Protocol Number: 2020P001875
PI: Waxman, Aaron B
Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Intervention: Pacritinib
Subject Population: Inpatient
Site: BWH
Status: Active, Enrolling