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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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