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NCT04575597 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,735
- Enrollment target
NCT04575597: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04575597 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,735 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1205% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04575597, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,735 participants
- Enrollment target
Study Summary
This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29
Primary Outcome
The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo f
Interventions
- DRUG Placebo
- DRUG Molnupiravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,735 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2022-05-05 |
| Phase | Phase 2 |
What the finished NCT04575597 record still lists
NCT04575597 is an interventional study that assigns participants to a tested intervention. Its 1,735 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1205% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04575597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04575597 about?
NCT04575597 is a clinical study titled "Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)". This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29
What is the current status of trial NCT04575597?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,735 participants. The study started on 2020-10-19. Estimated completion is 2022-05-05.
What interventions are being tested in trial NCT04575597?
The interventions under investigation include: Placebo (DRUG), Molnupiravir (DRUG).
Who is sponsoring clinical trial NCT04575597?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04575597's enrollment target sits among peer trials
1,735 11th of 2000 higher than 1,990 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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