Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,033

Participants

Timeline

Start Date

May 8, 2020

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
COVID-19
Interventions
OTHER

Placebo

The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet.

DRUG

Remdesivir

Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

DRUG

Baricitinib

Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

Trial Locations (71)

2100

University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases, Copenhagen

10016

New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology, New York

13620

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

14080

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia, Mexico City

Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas, Mexico City

17033

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

20007

Georgetown University Medical Center - Division of Infectious Diseases, Washington D.C.

20889

Walter Reed National Military Medical Center, Bethesda

21201

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore, Baltimore

23708

Naval Medical Center Portsmouth - Infectious Disease Division, Portsmouth

27704

Duke Human Vaccine Institute - Duke Vaccine and Trials Unit, Durham

28040

Hospital Clinico San Carlos - Enfermedades Infecciosas, Madrid

28310

Womack Army Medical Center - Pulmonary and Respiratory Services, Fort Bragg

29037

University of California San Diego Health - Jacobs Medical Center, La Jolla

30033

Atlanta VA Medical Center - Infectious Diseases Clinic, Decatur

32610

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

33136

University of Miami Miller School of Medicine - Infectious Diseases, Miami

35233

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

46202

Indiana University School of Medicine - Infectious Diseases, Indianapolis

60612

University of Illinois at Chicago College of Medicine - Division of Infectious Diseases, Chicago

70065

Ochsner Medical Center - Kenner - Department of Infectious Diseases, Kenner

70119

Southeast Louisiana Veterans Health Care System (SLVHCS) - Section of Infectious Diseases, New Orleans

75246

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

78234

Brooke Army Medical Center, Fort Sam Houston

80045

Eastern Colorado Health Care System, Aurora

80204

Denver Health Division of Hospital Medicine - Main Campus, Denver

84132

University of Utah - Infectious Diseases, Salt Lake City

87106

University of New Mexico Clinical and Translational Science Center, Albuquerque

90095

University of California Los Angeles Medical Center - Westwood Clinic, Los Angeles

92314

Naval Medical Center San Diego - Infectious Disease Clinic, San Diego

97227

Kaiser Permanente Northwest - Center for Health Research, Portland

98034

EvergreenHealth Infectious Disease Service, Kirkland

98431

Madigan Army Medical Center - Infectious Disease Clinic, Tacoma

99204

Providence Sacred Heart Medical Center, Spokane

119228

National University Health System - Division of Infectious Diseases, Singapore

308442

National Centre for Infectious Diseases (NCID), Singapore

529889

Changi General Hospital - Clinical Trials and Research Unit (CTRU), Singapore

609606

Ng Teng Fong General Hospital - Infectious Disease Service, Singapore

92868-3298

University of California Irvine Medical Center - Infectious Disease, Orange

94304-1207

VA Palo Alto Health Care System - Infectious Diseases, Palo Alto

94304-1503

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

95817-1460

University of California Davis Medical Center - Internal Medicine - Infectious Disease, Sacramento

94110-2859

University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine, San Francisco

90048-1804

Cedars Sinai Medical Center, West Hollywood

30030-1705

Emory Vaccine Center - The Hope Clinic, Decatur

60611-2908

Northwestern Hospital - Infectious Disease, Chicago

21287-0005

Johns Hopkins Hospital - Medicine - Infectious Diseases, Baltimore

20892-1504

National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section, Bethesda

02114-2621

Massachusetts General Hospital - Infectious Diseases, Boston

01655-0002

University of Massachusetts Medical School - Infectious Diseases and Immunology, Worcester

55455-0341

University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine, Minneapolis

63104-1015

Saint Louis University - Center for Vaccine Development, St Louis

68198-5400

University of Nebraska Medical Center - Infectious Diseases, Omaha

14642-0001

University of Rochester Medical Center - Vaccine Research Unit, Rochester

10467-2401

Montefiore Medical Center - Infectious Diseases, The Bronx

19104-4863

University of Pennsylvania Perelman School of Medicine - Penn Institute for Immunology, Philadelphia

37232-0011

Vanderbilt University Medical Center - Infectious Diseases, Nashville

75390-8884

University of Texas Southwestern Medical Center - Internal Medicine - Infectious Diseases, Dallas

77555-0435

University of Texas Medical Branch - Division of Infectious Disease, Galveston

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

78229-3901

University of Texas Health Science Center at San Antonio - Infectious Diseases, San Antonio

22908-0816

University of Virginia - Acute Care Surgery, Charlottesville

162-8655

National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center, Tokyo

03080

Seoul National University Hospital, Seoul

08036

Hospital Clinic Barcelona, Servicio de Salud Internacional, Barcelona

08916

Hospital Germans Trias i Pujol - Servei Malalties Infeccioses, Barcelona

Unknown

Royal Sussex County Hospital - Department of Intensive Care Medicine, Brighton

Saint Thomas' Hospital - Directorate of Infection, City of London

St. James's University Hospital - Infectious Diseases, Leeds

Royal Victoria Infirmary - Department of Infectious Diseases, Newcastle upon Tyne

John Radcliffe Hospital, Oxford

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04401579 - Adaptive COVID-19 Treatment Trial 2 (ACTT-2) | Biotech Hunter | Biotech Hunter