Trials / Completed
CompletedNCT04575597
Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,735 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Molnupiravir | Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total) |
| DRUG | Placebo | Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total) |
Timeline
- Start date
- 2020-10-19
- Primary completion
- 2022-05-05
- Completion
- 2022-05-05
- First posted
- 2020-10-05
- Last updated
- 2023-06-28
- Results posted
- 2023-06-28
Locations
173 sites across 23 countries: United States, Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04575597. Inclusion in this directory is not an endorsement.