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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507227-36-00
Acronym
MK-4482-023
Enrollment
767
Registered
2025-02-06
Start date
2025-02-21
Completion date
Unknown
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 (COVID-19) infection

Brief summary

Percentage of Participants Who Experienced One or More of following through Day 29: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV), Percentage of Participants Who Experienced an Adverse Event (AE), Percentage of Participants Who Discontinued Study Intervention Due to AE

Detailed description

Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms, Change From Baseline in SARS-CoV-2 RNA titer, Percentage of Participants With Undetectable SARS-CoV-2 RNA, Percentage of Participants Who Experienced One or More of following through Day 29: All-cause Hospitalization or All-cause Mortality, Percentage of Participants With Clinically Important Medical Interventions Associated with COVID-19 related MAV or COVID-19 related hospitalization through Day 29, Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29, Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29

Interventions

DRUGMolnupiravir Matching placebo tablets

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of Participants Who Experienced One or More of following through Day 29: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV), Percentage of Participants Who Experienced an Adverse Event (AE), Percentage of Participants Who Discontinued Study Intervention Due to AE

Secondary

MeasureTime frame
Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms, Change From Baseline in SARS-CoV-2 RNA titer, Percentage of Participants With Undetectable SARS-CoV-2 RNA, Percentage of Participants Who Experienced One or More of following through Day 29: All-cause Hospitalization or All-cause Mortality, Percentage of Participants With Clinically Important Medical Interventions Associated with COVID-19 related MAV or COVID-19 related hospitalization through Day 29, Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29, Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29

Countries

Bulgaria, Finland, France, Germany, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026