Trials / Terminated
TerminatedNCT04575584
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 304 (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 rate of sustained recovery through Day 29.
Detailed description
This study was intended to include two parts: Part 1 was a dose-ranging phase 2 study, and Part 2 was a phase 3 study to evaluate the dose selected in Part 1. However, this study was terminated due to business reasons prior to conducting Part 2. Participants in Part 1 were followed until Month 7.
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
- 2021-08-11
- Completion
- 2021-08-11
- First posted
- 2020-10-05
- Last updated
- 2023-01-17
- Results posted
- 2022-08-16
Locations
89 sites across 17 countries: United States, Brazil, Canada, Chile, Colombia, France, Israel, Italy, Mexico, Philippines, Poland, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04575584. Inclusion in this directory is not an endorsement.