ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

PHASE2CompletedINTERVENTIONAL
Enrollment

527

Participants

Timeline

Start Date

October 23, 2020

Primary Completion Date

April 22, 2022

Study Completion Date

April 22, 2022

Conditions
COVID-19
Interventions
BIOLOGICAL

Lenzilumab

Lenzilumab is a first-in-class recombinant monoclonal antibody targeting soluble human GM-CSF, with potential immunomodulating activity, high binding affinity in the pM range, and 94% specificity to the human germline, which reduces immunogenicity.

OTHER

Placebo

Placebo for lenzilumab is commercially sourced 0.9% sodium chloride.

DRUG

Remdesivir

Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524.

Trial Locations (55)

11794

Stony Brook Medicine - Stony Brook University Hospital, Stony Brook

12601

Nuvance Health - Vassar Brothers Medical Center, Poughkeepsie

13620

Seoul National University Bundang Hospital - Division of Infectious Diseases, Bundang-gu Seongnam-si

14203

The State University of New York - University at Buffalo - Department of Medicine, Buffalo

17033

Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases, Hershey

18901

Doylestown Hospital, Doylestown

26506

West Virginia University - Infectious Diseases Clinic, Morgantown

27157

Wake Forest Baptist Health - Infectious Diseases, Winston-Salem

28209

Atrium Health ID Consultants & Infusion Care Specialists, Charlotte

30303

Grady Memorial Hospital, Atlanta

32224

Mayo Clinic Florida, Jacksonville

32610

University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine, Gainesville

35233

University of Alabama at Birmingham School of Medicine - Infectious Disease, Birmingham

40202

Norton Healthcare, Louisville

University of Louisville - Division of Infectious Diseases, Louisville

43614

University of Toledo Medical Center - Ruppert Clinic, Toledo

55415

Hennepin Healthcare Research Institute, Minneapolis

57701

Monument Health - Clinical Research, Rapid City

60190

Northwestern Medicine - Central DuPage Hospital - Infectious Disease, Winfield

60612

Cook County Health and Hospitals System - Ruth M Rothstein CORE Center, Chicago

Rush University Medical Center, Chicago

60640

Great Lakes Clinical Trials, Chicago

61801

Carle Foundation Hospital, Urbana

68105

University of Nebraska Medical Center - Infectious Diseases, Omaha

75246

Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants, Dallas

77030

Methodist Hospital - Houston, Houston

77701

Baptist Hospitals of Southeast Texas Site, Beaumont

79601

Hendrick Health - Hendrick Medical Center, Abilene

80023

St. Anthony Hospital North Health Campus, Westminster

80907

Penrose Hospital - Emergency Medicine, Colorado Springs

80923

St. Francis Medical Center, Colorado Springs

84132

University of Utah - Infectious Diseases, Salt Lake City

92663

Hoag Hospital Newport Beach, Newport Beach

93721

UCSF Fresno Center for Medical Education and Research - Clinical Research Center, Fresno

97701

St. Charles Health System - St. Charles Bend Hospital, Bend

85724-0001

The University of Arizona - Banner University Medical Center Tucson Campus - Tucson, Tucson

72205-7101

University of Arkansas for Medical Sciences, Little Rock

93306-4018

Kern Medical Center, Bakersfield

90089-0121

University of Southern California - Infectious Diseases, Los Angeles

94305-2200

Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases, Stanford

80228-1704

St. Anthony Hospital, Lakewood

06810

Nuvance Health Danbury Hospital - Infectious Disease, Danbury

06519-1612

Yale School of Medicine - The Anlyan Center for Medical Research & Education - Immunobiology, New Haven

06856

Nuvance Health - Norwalk Hospital - Asthma Pulmonary and Critical Care Medicine, Norwalk

30030-1705

The Hope Clinic of Emory University, Decatur

02115-6110

Brigham and Women's Hospital - Infectious Diseases, Boston

02118

Boston Medical Center - Center for Infectious Diseases - Shapiro Center, Boston

48073-6700

William Beaumont Hospital - Royal Oak Campus - Infectious Disease, Royal Oak

55905-0001

Mayo Clinic, Rochester - Infectious Diseases, Rochester

07631

Englewood Hospital, Englewood

10029-6504

Mount Sinai School of Medicine - Medicine - Infectious Diseases, New York

10461-1119

Jacobi Medical Center, The Bronx

10467-2401

Montefiore Medical Center - Infectious Diseases, The Bronx

02886

Kent County Memorial Hospital, Warwick

03080

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04583969 - ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 | Biotech Hunter | Biotech Hunter