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

NCT04939428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2441

Last updated 2024-09-26

Study results available
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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

DRUG

Molnupiravir

Four molnupiravir 200 mg capsules taken by mouth.

DRUG

Placebo

Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2022-11-16
Completion
2022-11-16
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939428 on ClinicalTrials.gov