This study looks at the safety and effectiveness of Remdesivir in treating COVID-19 inpeople who have been hospitalized with the infection and who have acute respiratoryfailure. Participants in the study will be treated with Remdesivir plus current standardof care (SOC), or with placebo plus current SOC.
This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to
evaluate the safety and efficacy of Remdesivir at improving outcomes for patients with
acute respiratory failure related to COVID-19.
This protocol will be adaptive, randomized, blinded and initially placebo-controlled.
Participants will receive standard of care (SOC) treatment as part of the protocol.
This protocol will be conducted in up to several hundred clinical sites. Participating
sites are affiliated with networks funded by the United States National Institutes of
Health (NIH) and the US Department of Veterans Affairs.
The protocol is for a Phase 3 study.
Participants will be followed for 90 days following randomization for the primary
endpoint and most secondary endpoints. Selected secondary endpoints will be measured at
180 days.
This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement
in recovery status at Day 90 for Remdesivir versus placebo with use of the ordinal
outcome. The planned sample size is 320 participants. Sample size may be re-estimated
before enrollment is complete based on an assessment of whether the pooled proportions of
the outcome are still consistent with adequate power for the hypothesized difference
measured by the odds ratio.
Randomization will be stratified by study site pharmacy and by receipt of invasive
mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) at enrollment.
Other agent-specific stratification factors may be considered.
An independent Data and Safety Monitoring Board (DSMB) will review interim safety and
efficacy data at least monthly. Pre-specified guidelines will be established to recommend
early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may
recommend discontinuation of an investigational agent if the risks are judged to outweigh
the benefits.
Biological: Remdesivir
Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all
subsequent doses 100 mg.
Biological: Remdesivir Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily
for 10 days.
Drug: Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone,
methylprednisolone or hydrocortisone may be administered as SOC.
Inclusion Criteria:
Refer to the master protocol (NCT04843761)
Exclusion Criteria:
Refer to the master protocol (NCT04843761)
Additional Exclusion Criteria:
- Prior receipt of any dose of remdesivir during the present illness
- GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis
- ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper
limit of normal
- Unwillingness to commit to avoid sex that may result in pregnancy for at least 7
days after completion of remdesivir vs. placebo
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
Tucson 5318313, Arizona 5551752, United States
UCSF Fresno (Site 203-005), 155 N. Fresno Street
Fresno 5350937, California 5332921, United States
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
Loma Linda 5367696, California 5332921, United States
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard
Los Angeles 5368361, California 5332921, United States
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
Los Angeles 5368361, California 5332921, United States
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
San Francisco 5391959, California 5332921, United States
UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.
San Francisco 5391959, California 5332921, United States
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
Stanford 5398563, California 5332921, United States
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
Aurora 5412347, Colorado 5417618, United States
Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B
Denver 5419384, Colorado 5417618, United States
MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.
Washington D.C. 4140963, District of Columbia 4138106, United States
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
Washington D.C. 4140963, District of Columbia 4138106, United States
Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.
Atlanta 4180439, Georgia 4197000, United States
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
Boston 4930956, Massachusetts 6254926, United States
Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street
Springfield 4951788, Massachusetts 6254926, United States
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place
New York 5128581, New York 5128638, United States
Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.
New York 5128581, New York 5128638, United States
Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street
The Bronx 5110266, New York 5128638, United States
Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street
The Bronx 5110266, New York 5128638, United States
Duke University Hospital (Site 301-006), 2301 Erwin Road
Durham 4464368, North Carolina 4482348, United States
Wake Forest Baptist Health (Site 210-001), Medical Center Blvd
Winston-Salem 4499612, North Carolina 4482348, United States
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740
Cincinnati 4508722, Ohio 5165418, United States
Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Ave.
Cleveland 5150529, Ohio 5165418, United States
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.
Cleveland 5150529, Ohio 5165418, United States
The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue
Columbus 4509177, Ohio 5165418, United States
Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road
Garfield Heights 5155499, Ohio 5165418, United States
Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road
Mayfield Heights 5162188, Ohio 5165418, United States
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
Portland 5746545, Oregon 5744337, United States
Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214
Charleston 4574324, South Carolina 4597040, United States
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
Nashville 4644585, Tennessee 4662168, United States
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
Dallas 4684888, Texas 4736286, United States
Houston Methodist Hospital (Site 301-028), 6565 Fannin Street
Houston 4699066, Texas 4736286, United States
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
Houston 4699066, Texas 4736286, United States
University of Texas Health Science Center (Site 203-006), 7000 Fannin St.
Houston 4699066, Texas 4736286, United States
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
Murray 5778755, Utah 5549030, United States
University of Utah Hospital (Site 211-002), 50 North Medical Drive
Salt Lake City 5780993, Utah 5549030, United States
UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.
Charlottesville 4752031, Virginia 6254928, United States
Harborview Medical Center (Site 208-001), 325 9th Ave.
Seattle 5809844, Washington 5815135, United States
Swedish Medical Center (Site 208-005), 747 Broadway
Seattle 5809844, Washington 5815135, United States
West Virginia University Medicine (Site 301-023), One Medical Center Drive
Morgantown 4815352, West Virginia 4826850, United States