1,010
Participants
Start Date
December 2, 2020
Primary Completion Date
May 18, 2021
Study Completion Date
June 18, 2021
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.
Dexamethasone
Dexamethasone Sodium Phosphate Injection, USP, is an adrenocortical steroid anti-inflammatory drug. It is a water-soluble inorganic ester of dexamethasone. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant.
Placebo
Placebo matching oral baricitinib or intravenous dexamethasone.
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.
Seoul National University Bundang Hospital - Division of Infectious Diseases, Bundang-gu Seongnam-si
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
Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases, Hershey
Georgetown University Medical Center - Division of Infectious Diseases, Washington D.C.
Walter Reed National Military Medical Center, Bethesda
Naval Medical Center Portsmouth - Infectious Disease Division, Portsmouth
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit, Durham
Womack Army Medical Center - Pulmonary and Respiratory Services, Fort Bragg
University of California San Diego Health - Jacobs Medical Center, La Jolla
Atlanta VA Medical Center - Infectious Diseases Clinic, Decatur
University of Florida Health - Jacksonville - Department of Emergency Medicine, Jacksonville
University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine, Gainesville
University of Miami Miller School of Medicine - Infectious Diseases, Miami
University of Alabama at Birmingham School of Medicine - Infectious Disease, Birmingham
University of Michigan - Infectious Disease Clinic at Taubman Center, Ann Arbor
University of Iowa Hospitals & Clinics - Department of Internal Medicine, Iowa City
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases, Chicago
University of Nebraska Medical Center - Infectious Diseases, Omaha
CHI Health Creighton University Medical Center - Bergan Mercy - Pulmonary Medicine, Omaha
Tulane University - Section of Pulmonary Diseases, Critical Care, and Environmental Medicine, New Orleans
University of Oklahoma Health Science Center - Surgery, Oklahoma City
Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants, Dallas
Brooke Army Medical Center, Fort Sam Houston
VA Eastern Colorado Health Care System, Aurora
Denver Health Division of Hospital Medicine - Main Campus, Denver
University of New Mexico Clinical and Translational Science Center, Albuquerque
University of California Los Angeles Medical Center - Westwood Clinic, Los Angeles
Kaiser Permanente San Diego Medical Center, San Diego
Naval Medical Center San Diego - Infectious Disease Clinic, San Diego
UCSF Fresno Center for Medical Education and Research - Clinical Research Center, Fresno
Tripler Army Medical Center, Honolulu
Kaiser Permanente Northwest - Center for Health Research, Portland
EvergreenHealth Infectious Disease Service, Kirkland
Madigan Army Medical Center - Infectious Disease Clinic, Tacoma
Providence Sacred Heart Medical Center, Spokane
National University Health System - Division of Infectious Diseases, Singapore
National University Health System - Alexandra Hospital - Division of Infectious Diseases, Singapore
National Centre for Infectious Diseases, Singapore
Changi General Hospital - Clinical Trials and Research Unit (CTRU), Singapore
Ng Teng Fong General Hospital - Infectious Disease Service, Singapore
University of California Irvine Medical Center - Infectious Disease, Orange
VA Palo Alto Health Care System - Infectious Diseases, Palo Alto
University of California Davis Medical Center - Internal Medicine - Infectious Disease, Sacramento
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine, San Francisco
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases, Stanford
Cedars Sinai Medical Center, West Hollywood
Emory Vaccine Center - The Hope Clinic, Decatur
Northwestern Hospital - Infectious Disease, Chicago
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore, Baltimore
Johns Hopkins Hospital - Medicine - Infectious Diseases, Baltimore
National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section, Bethesda
Massachusetts General Hospital - Infectious Diseases, Boston
University of Massachusetts Medical School - Infectious Diseases and Immunology, Worcester
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine, Minneapolis
Saint Louis University - Center for Vaccine Development, St Louis
Atlantic Health System - Morristown Medical Center, Morristown
New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology, New York
University of Rochester Medical Center - Vaccine Research Unit, Rochester
Montefiore Medical Center - Infectious Diseases, The Bronx
Hospital of the University of Pennsylvania - Infectious Diseases, Philadelphia
University of Pittsburgh - Medicine - Infectious Diseases, Pittsburgh
University of Texas Southwestern Medical Center - Internal Medicine - Infectious Diseases, Dallas
University of Texas Medical Branch - Division of Infectious Disease, Galveston
Methodist Hospital - Houston, Houston
Baylor College of Medicine - Molecular Virology and Microbiology, Houston
University of Texas Health Science Center at San Antonio - Infectious Diseases, San Antonio
University of Utah - Infectious Diseases, Salt Lake City
University of Virginia - Acute Care Surgery, Charlottesville
Tokyo Medical and Dental University - Medical Hospital - Department of Respiratory Medicine, Tokyo
National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center, Tokyo
Seoul National University Hospital, Seoul
National Institute of Allergy and Infectious Diseases (NIAID)
NIH