A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)

PHASE2CompletedINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

April 15, 2020

Primary Completion Date

December 1, 2020

Study Completion Date

April 1, 2021

Conditions
COVID-19
Interventions
DRUG

Gimsilumab

Gimsilumab is a fully human monoclonal antibody (mAb).

DRUG

Placebo

Normal saline

Trial Locations (33)

10003

Mount Sinai Beth Israel, New York

10019

Mount Sinai West, New York

10025

Mount Sinai Morningside, New York

10029

Icahn School of Medicine at Mount Sinai, New York

11418

Jamaica Hospital Medical Center, Jamaica

19140

Temple University Hospital, Philadelphia

22042

Inova Fairfax Medical Campus, Falls Church

30309

Piedmont Healthcare, Atlanta

30322

Emory University School of Medicine, Atlanta

32610

University of Florida, Gainesville

33176

Miami Cancer institute, Miami

37232

Vanderbilt University Medical Center, Nashville

44106

University Hospitals Cleveland Medical Center, Cleveland

48073

Beaumont Hospital - Royal Oak, Royal Oak

60201

NorthShore University HealthSystem, Evanston

70006

East Jefferson General Hospital, Metairie

75061

Baylor Scott & White All Saints Medical Center, Fort Worth

Baylor Scott & White Medical Center, Irving

75093

Baylor Scott & White Heart Hospital, Plano

Baylor Scott & White Medical Center, Plano

75226

Baylor Jack & Jane Hamilton Heart and Vascular Hospital, Dallas

75246

Baylor University Medical Center, Dallas

76508

Baylor Scott & White Medical Center, Temple

77030

Memorial Hermann Hospital Affiliated with University of Texas Health Science Center at Houston, McGovern Medical School, Houston

78665

Baylor Scott & White Medical Center, Round Rock

85006

Banner University Medical Center, Phoenix

85020

HonorHealth John C. Lincoln Medical Center, Phoenix

85251

HonorHealth Scottsdale Osborn Medical Center, Scottsdale

85258

HonorHealth, Scottsdale

85260

HonorHealth Scottsdale Shea Medical Center, Scottsdale

85719

Banner University Medical Center, Tucson

90095

UCLA Ronald Reagan Medical Center, Los Angeles

02115

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

Roivant Sciences, Inc.

INDUSTRY

lead

Kinevant Sciences GmbH

INDUSTRY