CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,735 enrolled
Drug / intervention
Molnupiravir +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04575597
NCT04575597Phase 3Completed

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.

Merck Sharp & Dohme LLC·interventional·Posted Oct 5, 2020·Updated Jun 28, 2023

In Brief

A Phase 3 clinical trial evaluating Molnupiravir and Placebo for Coronavirus Disease (COVID-19). Completed, enrolled 1,735 participants across 173 sites in 23 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 5, 2020
Enrollment StartOct 19, 2020
Primary CompletionMay 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.7 years ago

Interventions

Molnupiravirdrug

Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)

Placebodrug

Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)