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Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

NCT04575597 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1735

Last updated 2023-06-28

Study results available
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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

Conditions

  • Coronavirus Disease (COVID-19)

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2022-05-05
Completion
2022-05-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Egypt
  • France
  • Germany
  • Guatemala
  • Israel
  • Italy
  • Japan
  • Mexico
  • Philippines
  • Poland
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

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 NCT04575597 on ClinicalTrials.gov