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

Phase 3

Recruiting

• Conditions: Coronavirus Disease (COVID-19)
• Interventions: Drug: Molnupiravir; Drug: Placebo

• Registration Number: NCT06667700
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect.

Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Study Start: 2024-12-02
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-25
• Primary Completion: 2031-01-26
• Study Completion: 2031-01-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3082

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Molnupiravir	Molnupiravir	Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)
Placebo	Placebo	Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)

Primary Outcome Measures

Name	Time	Method
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)	Up to 29 days	Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. As prespecified by the protocol, the percentage of participants who experience ONE OR MORE of these 3 events (hospitalization, death, or COVID-19-related MAV) occurring from randomization through Day 29 will be presented.
Percentage of Participants Who Experience an Adverse Event (AE)	Up to approximately 5 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.
Percentage of Participants Who Discontinue Study Intervention Due to AE	Up to approximately 5 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Day 1 (baseline) and up to Day 29	SARS-CoV-2 RNA titer (viral load) will be measured by quantitative reverse transcriptase polymerase chain reaction (RT-PCR) of samples from nasopharyngeal (NP) swabs, and the mean change from baseline will be presented.
Percentage of Participants with Undetectable SARS-CoV-2 Viral Load	Up to 29 days	SARS-CoV-2 RNA (viral load) will be measured by quantitative RT-PCR of samples from NP swabs, and the percentage of participants with undetectable (i.e., below the lower limit of quantification) SARS-CoV-2 RNA (viral load) will be presented.
Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29	Up to 29 days	CIMIs were prespecified by the protocol and include, but are not limited to, supplemental oxygen therapy, IV fluid administration, and nebulizer treatment. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. The percentage of participants with CIMIs associated with a COVID-19-related MAV AND/OR a COVID-19-related hospitalization through Day 29 will be reported.
Time to Sustained Alleviation Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29	Up to 29 days	Time to sustained alleviation without relapse is defined as the number of days from randomization to the first of 2 consecutive days when alleviation (lessening of symptoms) is demonstrated, collectively, for all 8 selected COVID-19-related sign/symptoms. Participants who experience sustained alleviation for 2 consecutive days must not relapse in any of the 8 signs/symptoms before Day 29. The time to sustained alleviation without relapse of all 8 selected COVID-19-related signs/symptoms from randomization through Day 29 will be presented.
Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality	Up to 29 days	Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. As prespecified by the protocol, the percentage of participants who experience hospitalization AND/OR death occurring from randomization through Day 29 will be presented.
Time to Sustained Alleviation Without Relapse of All 15 COVID-19-related Signs/Symptoms Through Day 29	Up to 29 days	Time to sustained alleviation without relapse is defined as the number of days from randomization to the first of 2 consecutive days when alleviation (lessening of symptoms) is demonstrated, collectively, for all 15 COVID-19-related sign/symptoms. Participants who experience sustained alleviation after 2 consecutive days must not relapse in any of the 15 signs/symptoms before Day 29. The time to sustained alleviation without relapse of all 15 COVID-19-related signs/symptoms from randomization through Day 29 will be presented.
Time to Sustained Resolution Without Relapse of All 8 Selected COVID-19-related Signs/Symptoms Through Day 29	Up to 29 days	Time to sustained resolution without relapse is defined as the number of days from randomization to the first of 2 consecutive days when resolution (having no symptoms or only mild symptoms) is demonstrated, collectively, for all 8 selected COVID-19-related sign/symptoms. Participants who experience sustained resolution after 2 consecutive days must not relapse in any of the 8 signs/symptoms before Day 29. The time to sustained resolution without relapse of all 8 selected COVID-19-related signs/symptoms from randomization through Day 29 will be presented.

Trial Locations

Locations (189)

Cullman Clinical Trials ( Site 3813); 🇺🇸 Cullman, Alabama, United States

Helios Clinical Research ( Site 3826); 🇺🇸 Paradise Valley, Arizona, United States

Absolute Clinical Research ( Site 3709); 🇺🇸 Phoenix, Arizona, United States

Clinica de Salud del Valle de Salinas ( Site 3825); 🇺🇸 Castroville, California, United States

Ascada Health PC dba Ascada Research ( Site 3750); 🇺🇸 Fullerton, California, United States

Pacific Clinical Studies ( Site 3827); 🇺🇸 Los Alamitos, California, United States

Valley Clinical Trials, Inc. ( Site 3707); 🇺🇸 Northridge, California, United States

FOMAT Medical Research ( Site 3720); 🇺🇸 Oxnard, California, United States

Paradigm Clinical Research, LLC ( Site 3785); 🇺🇸 San Diego, California, United States

Optimus Medical ( Site 3817); 🇺🇸 San Francisco, California, United States

Scroll for more (179 remaining)