Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

Completed · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

This study looks at the safety and effectiveness of Remdesivir in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Remdesivir plus current standard of care (SOC), or with placebo plus current SOC.

Key facts

Study ID

NCT06729593

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

87

Starts

2021-04-20

Expected to finish

2022-11-20

Last updated by the study team

2025-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Refer to the master protocol (NCT04843761)

You may not qualify if…

• 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

Where it is running

• Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue — Tucson, Arizona, United States
• UCSF Fresno (Site 203-005), 155 N. Fresno Street — Fresno, California, United States
• VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street — Loma Linda, California, United States
• Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza — Los Angeles, California, United States
• UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St. — San Francisco, California, United States
• UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave. — San Francisco, California, United States
• Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr. — Stanford, California, United States
• University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue — Aurora, Colorado, United States
• Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B — Denver, Colorado, United States
• MedStar Health Research Institute (Site 009-021), 110 Irving St., NW. — Washington D.C., District of Columbia, United States
• Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW. — Washington D.C., District of Columbia, United States
• Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE. — Atlanta, Georgia, United States
• Massachusetts General Hospital (Site 202-002), 55 Fruit Street — Boston, Massachusetts, United States
• Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street — Springfield, Massachusetts, United States
• Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place — New York, New York, United States
• Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave. — New York, New York, United States
• Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street — The Bronx, New York, United States
• Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street — The Bronx, New York, United States
• Duke University Hospital (Site 301-006), 2301 Erwin Road — Durham, North Carolina, United States
• Wake Forest Baptist Health (Site 210-001), Medical Center Blvd — Winston-Salem, North Carolina, United States
• University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740 — Cincinnati, Ohio, United States
• Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Ave. — Cleveland, Ohio, United States
• Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave. — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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