473
Participants
Start Date
April 20, 2021
Primary Completion Date
August 22, 2022
Study Completion Date
November 20, 2022
Remdesivir
Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.
Remdesivir Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.
Aviptadil
Administered by IV infusion over 12 hours per day for 3 days. Participants are no longer being randomized to this intervention.
Aviptadil Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.
Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York
Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave., New York
Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street, The Bronx
Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street, The Bronx
MedStar Health Research Institute (Site 009-021), 110 Irving St., NW., Washington D.C.
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW., Washington D.C.
UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St., Charlottesville
West Virginia University Medicine (Site 301-023), One Medical Center Drive, Morgantown
Wake Forest Baptist Health (Site 210-001), Medical Center Blvd, Winston-Salem
Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham
Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214, Charleston
Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE., Atlanta
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive, Nashville
The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue, Columbus
Cleveland Clinic Fairview Hosptial (Site 207-005), 18101 Lorain Ave., Cleveland
Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road, Mayfield Heights
Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road, Garfield Heights
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave., Cleveland
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740, Cincinnati
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave., Dallas
Houston Methodist Hospital (Site 301-028), 6565 Fannin Street, Houston
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266, Houston
University of Texas Health Science Center (Site 203-006), 7000 Fannin St., Houston
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue, Aurora
Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B, Denver
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street, Murray
University of Utah Hospital (Site 211-002), 50 North Medical Drive, Salt Lake City
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue, Tucson
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard, Los Angeles
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza, Los Angeles
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street, Loma Linda
UCSF Fresno (Site 203-005), 155 N. Fresno Street, Fresno
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St., San Francisco
UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave., San Francisco
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr., Stanford
Harborview Medical Center (Site 208-001), 325 9th Ave., Seattle
Swedish Medical Center (Site 208-005), 747 Broadway, Seattle
Massachusetts General Hospital (Site 202-002), 55 Fruit Street, Boston
Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street, Springfield
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd., Portland
Collaborators (4)
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
NETWORK
University of Copenhagen
OTHER
Medical Research Council
OTHER_GOV
Kirby Institute
OTHER_GOV
Washington D.C. Veterans Affairs Medical Center
FED
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Heart, Lung, and Blood Institute (NHLBI)
NIH
US Department of Veterans Affairs
FED
Prevention and Early Treatment of Acute Lung Injury
OTHER
Cardiothoracic Surgical Trials Network
OTHER
NeuroRx, Inc.
INDUSTRY
Gilead Sciences
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH