Recruiting

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06667700

Conditions

Coronavirus Disease (COVID-19)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Molnupiravir

Placebo

Study Details

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.

Conditions

Coronavirus Disease (COVID-19)

Study ID

NCT06667700

Start date

Dec 2, 2024

Status verified date

Oct, 2026

Completion date

Jan 26, 2031

Anticipated

Primary completion date

Jan 26, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

Is an individual of any sex/gender, ≥18 years of age
Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization
Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever >38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache
Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:

Advanced age of ≥75 years of age
Immunocompromised
Neurocognitive or physical disability
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 (BMI) ≥35, diabetes)
Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following:

Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible
Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
Has severe hepatic impairment
Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
Has known or suspected NMV/r resistance
Has uncontrolled HIV infection
NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)
Is unwilling to receive treatment with NMV/r

Inclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study.

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)
Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19:

Shortness of breath at rest
Respiratory rate ≥30 breaths per minute
Heart rate ≥125 beats per minute
Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms
New or increasing need for supplemental oxygen: receiving >4 liters/minute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19
Has received a COVID-19 vaccine within 30 days prior to randomization
Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization
Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Study Design

Enrollment

3082 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Molnupiravir

Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)

placebo comparator: Placebo

Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)

Interventions

Molnupiravir

Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Placebo

Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Primary outcome measure

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) [ Time Frame: Up to 29 days ]
Percentage of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 5 months ]
Percentage of Participants Who Discontinued Study Intervention Due to AE [ Time Frame: Up to approximately 5 days ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Helios Clinical Research ( Site 3826)

Recruiting

Paradise Valley, Arizona, United States, 85253

Contacts

Study Coordinator

480-659-0448

Clinica de Salud del Valle de Salinas ( Site 3825)

Recruiting

Castroville, California, United States, 95012

Contacts

Study Coordinator

805-483-1185

Pacific Clinical Studies ( Site 3827)

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Study Coordinator

5625980600x205

Valley Clinical Trials, Inc. ( Site 3707)

Recruiting

Northridge, California, United States, 91325

Contacts

Study Coordinator

818-280-4220

FOMAT Medical Research ( Site 3720)

Recruiting

Oxnard, California, United States, 93030

Contacts

Study Coordinator

805-483-1185

Paradigm Clinical Research, LLC ( Site 3785)

Recruiting

San Diego, California, United States, 91208

Contacts

Study Coordinator

858274426

Optimus Medical ( Site 3817)

Recruiting

San Francisco, California, United States, 94102

Contacts

Study Coordinator

415-518-1292

Millennium Clinical Trials ( Site 3758)

Recruiting

Westlake Village, California, United States, 91361

Contacts

Study Coordinator

805-496-3322

Paradigm Clinical Research Centers, Inc ( Site 3718)

Recruiting

Wheat Ridge, Colorado, United States, 80033

Contacts

Study Coordinator

303-463-1947

Encore Medical Research of Boynton Beach ( Site 3701)

Recruiting

Boynton Beach, Florida, United States, 33436

Contacts

Study Coordinator

561-774-8799

Prestige Clinical Research Center ( Site 3722)

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Study Coordinator

305-907-6960

Prestige Clinical Research ( Site 3830)

Recruiting

Homestead, Florida, United States, 33030

Contacts

Study Coordinator

305-907-6961

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)

Recruiting

Largo, Florida, United States, 33777

Contacts

Study Coordinator

727-347-8839

Clinical Site Partners, LLC dba Flourish Research ( Site 3717)

Recruiting

Leesburg, Florida, United States, 34748

Contacts

Study Coordinator

325-435-7240

Southern Clinical Research ( Site 3773)

Recruiting

Miami, Florida, United States, 33125

Contacts

Study Coordinator

844-312-1727

Florida Pharmaceutical Research and Associates ( Site 3763)

Recruiting

Miami, Florida, United States, 33143

Contacts

Study Coordinator

786-254-7296

Bio-Medical Research LLC ( Site 3804)

Recruiting

Miami, Florida, United States, 33144

Contacts

Study Coordinator

305-671-3686

Miami Clinical Research ( Site 3729)

Recruiting

Miami, Florida, United States, 33155

Contacts

Study Coordinator

305-433-6496

Reed Medical Research ( Site 3761)

Recruiting

Miami, Florida, United States, 33176

Contacts

Study Coordinator

305-413-0531

Palm Springs Community Health Center ( Site 3757)

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Study Coordinator

786-334-6675

Panax Clinical Research ( Site 3803)

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Study Coordinator

305-698-4500

Indago Research and Health Center Inc ( Site 3714)

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Study Coordinator

305-825-6588

Combined Research Orlando Phase I-IV ( Site 3797)

Recruiting

Orlando, Florida, United States, 32807

Contacts

Study Coordinator

407-440-4493

CDC Research Institute ( Site 3716)

Recruiting

Port Saint Lucie, Florida, United States, 34952

Contacts

Study Coordinator

772-807-1636

New Tampa Health ( Site 3764)

Recruiting

Tampa, Florida, United States, 33603

Contacts

Study Coordinator

813-440-6355

Clinical Research Trials of Florida ( Site 3703)

Recruiting

Tampa, Florida, United States, 33607

Contacts

Study Coordinator

813-873-8102

Precision Research Center ( Site 3704)

Recruiting

Tampa, Florida, United States, 33614

Contacts

Study Coordinator

813-513-2365

Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)

Recruiting

Lawrenceville, Georgia, United States, 30046

Contacts

Study Coordinator

770-696-4541

Renew Health Clinical Research ( Site 3760)

Recruiting

Snellville, Georgia, United States, 30078

Contacts

Study Coordinator

706-223-3560

Rush University Medical Center ( Site 3748)

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Study Coordinator

312-942-5987

Duly Health and Care ( Site 3799)

Recruiting

Lombard, Illinois, United States, 60148

Contacts

Study Coordinator

630-545-7760

University of Louisville School of Medicine ( Site 3706)

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Study Coordinator

502-852-3836

Annapolis Internal Medicine - CCT Research ( Site 3700)

Recruiting

Annapolis, Maryland, United States, 21401

Contacts

Study Coordinator

410-824-1005

Kur Research - Columbia Medical ( Site 3767)

Recruiting

Columbia, Maryland, United States, 21045

Contacts

Study Coordinator

410-964-8522

Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Study Coordinator

313-343-6311

Mankato Clinic ( Site 3842)

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Study Coordinator

507-625-1811

SKY Integrative Medical Center/SKYCRNG ( Site 3740)

Recruiting

Ridgeland, Mississippi, United States, 39157

Contacts

Study Coordinator

601-617-7717

Nevada Health Centers ( Site 3840)

Recruiting

Carson City, Nevada, United States, 89706

Contacts

Study Coordinator

770-200-9775

WR-CRCN, LLC ( Site 3818)

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Study Coordinator

702-893-8968

Saint Michael's Medical Center ( Site 3808)

Recruiting

Newark, New Jersey, United States, 07102

Contacts

Study Coordinator

973-877-5162

Holy Name Medical Center ( Site 3807)

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Study Coordinator

201-833-3000

Weill Cornell Medical College ( Site 3814)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

212-746-7587

Prime Global Research ( Site 3731)

Recruiting

The Bronx, New York, United States, 10456

Contacts

Study Coordinator

718-676-9444

OnSite Clinical Solutions ( Site 3784)

Recruiting

Charlotte, North Carolina, United States, 28277

Contacts

Study Coordinator

800-785-3150

Monroe Biomedical Research ( Site 3732)

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Study Coordinator

704-283-7359

IMA Clinical Research Mount Airy ( Site 3745)

Recruiting

Mount Airy, North Carolina, United States, 27030

Contacts

Study Coordinator

336-415-5507

Helios Clinical Research - JAC ( Site 3833)

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Study Coordinator

731-431-5027

Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)

Recruiting

Conroe, Texas, United States, 77384

Contacts

Study Coordinator

281-639-5061

South Texas Clinical Research ( Site 3815)

Recruiting

Corpus Christi, Texas, United States, 78404

Contacts

Study Coordinator

361-288-4668

Houston Methodist Hospital ( Site 3800)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-441-3250

MD Anderson ( Site 3843)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-792-6830

Andres Garcia Zuniga, M.D., P.A. ( Site 3782)

Recruiting

Laredo, Texas, United States, 78041

Contacts

Study Coordinator

956-307-4280

LinQ Research ( Site 3824)

Recruiting

Pearland, Texas, United States, 77584

Contacts

Study Coordinator

281-916-4220

Crossroads Clinical Research-Family Practice ( Site 3739)

Recruiting

Victoria, Texas, United States, 77901

Contacts

Study Coordinator

361-574-7800

Velocity Clinical Research - Hampton ( Site 3744)

Recruiting

Hampton, Virginia, United States, 23666

Contacts

Study Coordinator

757-520-5111

Eastside Research Associates ( Site 3727)

Recruiting

Redmond, Washington, United States, 98052

Contacts

Study Coordinator

425-869-6828

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.