NCT04939428

Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,441 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

Conditions

• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
DRUG	Molnupiravir	Four molnupiravir 200 mg capsules taken by mouth.
DRUG	Placebo	Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.

Timeline

• Start date: 2021-08-11
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2021-06-25
• Last updated: 2024-09-26
• Results posted: 2024-02-06

Locations

226 sites across 23 countries: United States, Argentina, Brazil, Bulgaria, Colombia, Dominican Republic, Egypt, France, Guatemala, Hungary, Japan, Kenya, Malaysia, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study