NCT06667700

A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,082 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect. Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Conditions

• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
DRUG	Molnupiravir	Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
DRUG	Placebo	Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Timeline

• Start date: 2024-12-02
• Primary completion: 2031-01-26
• Completion: 2031-01-26
• First posted: 2024-10-31
• Last updated: 2026-04-13

Locations

219 sites across 24 countries: United States, Argentina, Brazil, Bulgaria, Colombia, Finland, France, Georgia, Germany, Italy, Japan, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study