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Anti-viral

Molnupiravir for COVID-19 (MOVe-NOW Trial)

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index ≥35, diabetes)

Is unable to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the specified reasons

Must not have

Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently

Has received a COVID-19 vaccine within 30 days prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called Molnupiravir to see if it can prevent severe illness from COVID-19 in high-risk individuals. The medication is designed to stop the virus from

Who is the study for?

This trial is for adults over 18 at high risk of severe COVID-19 due to factors like advanced age (≥75), certain chronic conditions, or being immunocompromised. Participants must have early-stage symptoms and confirmed SARS-CoV-2 infection. Those with severe kidney or liver issues, taking specific other medications, or unable to take existing treatments may qualify.

What is being tested?

The study compares Molnupiravir, a medication intended to prevent the COVID-19 virus from multiplying in the body, against a placebo. The main goal is to see if Molnupiravir can better prevent serious illness from COVID-19 in high-risk individuals.

What are the potential side effects?

Potential side effects of Molnupiravir are not detailed here but generally could include typical drug reactions such as digestive discomfort, headaches, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have 3 or more conditions that make COVID-19 riskier for me.

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I cannot take NMV/r due to specific reasons.

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I started showing COVID-19 symptoms less than 4 days ago and have at least two of the listed symptoms today.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am in the hospital or will be soon due to COVID-19.

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I have been vaccinated for COVID-19 in the last 30 days.

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I am receiving or planning to receive COVID-19 antivirals or monoclonal antibodies.

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I have severe symptoms due to COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Who Discontinue Study Intervention Due to AE

Percentage of Participants Who Experience an Adverse Event (AE)

Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization, All-cause Mortality, or Covid-19-related Medically-attended Visit (MAV)

Secondary study objectives

Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load

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 (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29

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