What is molnupiravir studying for COVID-19?

Molnupiravir is being studied to see if it can prevent severe illness from COVID-19 in adults at high risk. Researchers want to understand if molnupiravir reduces hospitalizations, deaths, or serious medical visits related to COVID-19. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide more treatment options for high-risk individuals.

Who may be eligible for this COVID-19 clinical trial?

Adults aged 18 years or older with a recent confirmed COVID-19 infection may be eligible. Participants must have symptoms and be at high risk for severe illness, such as older age or certain medical conditions. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this COVID-19 clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should consider their own travel arrangements when joining the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06667700

Phase 3 Study of Molnupiravir to Prevent Severe COVID-19 Illness in High-Risk Adults Not Hospitalized

Led by Merck Sharp & Dohme LLC · Updated on 2026-08-10

3082

Participants Needed

224

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Confirmed SARS-CoV-2 infection with sample collected within 4 days before randomization
Onset of COVID-19 symptoms within 4 days before randomization
At least 2 COVID-19 symptoms on the day of randomization (e.g., cough, sore throat, fever)
At least 1 high-risk factor for severe COVID-19 (e.g., age 75 or older, immunocompromised, neurocognitive or physical disability, or 3 or more risk conditions like chronic lung disease or obesity)
Unable or unwilling to receive nirmatrelvir/ritonavir treatment due to medical or accessibility reasons

You will not qualify if you...

Currently hospitalized or expected to need hospitalization for COVID-19
Received or planning to receive other oral antivirals or monoclonal antibodies for current COVID-19 episode (except study drug or remdesivir)
Signs of severe or critical COVID-19 such as shortness of breath at rest, high respiratory or heart rate, low oxygen saturation, or increased oxygen needs
Received a COVID-19 vaccine within 30 days before randomization
History of influenza, RSV, or previous COVID-19 infection within 30 days prior to randomization
Known or suspected allergy to molnupiravir ingredients

Research Team

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