CompletedPhase 3

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

United States87 participantsStarted 2021-04-20

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90

Timeframe: Status on Day 90

Trial details

NCT IDNCT06729593

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2022-08-22

Results submitted2025-05-29

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