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RECRUITING

NCT06667700

PHASE3

A 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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3082

Start Date

2024-12-02

Completion Date

2031-01-26

Last Updated

2026-10-20

Healthy Volunteers

Conditions

Coronavirus Disease (COVID-19)

Interventions

DRUG

Molnupiravir

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

DRUG

Placebo

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

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

Locations (227)

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

Millennium Clinical Trials ( Site 3758)

Westlake Village, California, United States

Paradigm Clinical Research Centers, Inc ( Site 3718)

Wheat Ridge, Colorado, United States

Encore Medical Research of Boynton Beach ( Site 3701)

Boynton Beach, Florida, United States

Prestige Clinical Research Center ( Site 3722)

Coral Gables, Florida, United States

Prestige Clinical Research ( Site 3830)

Homestead, Florida, United States

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

Largo, Florida, United States

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

Leesburg, Florida, United States

Advanced Pulmonary Research Institute ( Site 3781)

Loxahatchee Groves, Florida, United States

Southern Clinical Research ( Site 3773)

Miami, Florida, United States

Florida Pharmaceutical Research and Associates ( Site 3763)

Miami, Florida, United States

Bio-Medical Research LLC ( Site 3804)

Miami, Florida, United States

Bright Research Center ( Site 3746)

Miami, Florida, United States

Miami Clinical Research ( Site 3729)

Miami, Florida, United States

Reed Medical Research ( Site 3761)

Miami, Florida, United States

Palm Springs Community Health Center ( Site 3757)

Miami Lakes, Florida, United States

Panax Clinical Research ( Site 3803)

Miami Lakes, Florida, United States

Indago Research and Health Center Inc ( Site 3714)

Miami Lakes, Florida, United States

Combined Research Orlando Phase I-IV ( Site 3797)

Orlando, Florida, United States

CDC Research Institute ( Site 3716)

Port Saint Lucie, Florida, United States

New Tampa Health ( Site 3764)

Tampa, Florida, United States

Clinical Research Trials of Florida ( Site 3703)

Tampa, Florida, United States

Precision Research Center ( Site 3704)

Tampa, Florida, United States

Encore Medical Research - Weston ( Site 3708)

Weston, Florida, United States

Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)

Lawrenceville, Georgia, United States

Renew Health Clinical Research ( Site 3760)

Snellville, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)

Union City, Georgia, United States

Paradigm Clinical Research - Boise ( Site 3841)

Boise, Idaho, United States

Rush University Medical Center ( Site 3748)

Chicago, Illinois, United States

Duly Health and Care ( Site 3799)

Lombard, Illinois, United States

University of Louisville School of Medicine ( Site 3706)

Louisville, Kentucky, United States

Barnum Medical Research ( Site 3828)

Natchitoches, Louisiana, United States

Annapolis Internal Medicine - CCT Research ( Site 3700)

Annapolis, Maryland, United States

Kur Research - Columbia Medical ( Site 3767)

Columbia, Maryland, United States

Revival Research Institute, LLC ( Site 3835)

Dearborn, Michigan, United States

Michigan Center of Medical Research (MICHMER) ( Site 3734)

Farmington Hills, Michigan, United States

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

Grosse Pointe Woods, Michigan, United States

Mankato Clinic ( Site 3842)

Mankato, Minnesota, United States

Prime Health and Wellness/SKYCRNG ( Site 3726)

Fayette, Mississippi, United States

SKY Integrative Medical Center/SKYCRNG ( Site 3740)

Ridgeland, Mississippi, United States

Nevada Health Centers ( Site 3840)

Carson City, Nevada, United States

WR-CRCN, LLC ( Site 3818)

Las Vegas, Nevada, United States

Saint Michael's Medical Center ( Site 3808)

Newark, New Jersey, United States

Holy Name Medical Center ( Site 3807)

Teaneck, New Jersey, United States

Weill Cornell Medical College ( Site 3814)

New York, New York, United States

Prime Global Research ( Site 3731)

The Bronx, New York, United States

OnSite Clinical Solutions ( Site 3784)

Charlotte, North Carolina, United States

Monroe Biomedical Research ( Site 3732)

Monroe, North Carolina, United States

IMA Clinical Research Mount Airy ( Site 3745)

Mount Airy, North Carolina, United States

Research Innovations, LLC ( Site 3712)

Beavercreek, Ohio, United States

Midlands Neurology & Pain Associates ( Site 3751)

Columbia, South Carolina, United States

Helios Clinical Research - JAC ( Site 3833)

Jackson, Tennessee, United States

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

Conroe, Texas, United States

South Texas Clinical Research ( Site 3815)

Corpus Christi, Texas, United States

Care United Research, LLC ( Site 3747)

Forney, Texas, United States

Houston Methodist Hospital ( Site 3800)

Houston, Texas, United States

MD Anderson ( Site 3843)

Houston, Texas, United States

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

Laredo, Texas, United States

LinQ Research ( Site 3824)

Pearland, Texas, United States

Crossroads Clinical Research-Family Practice ( Site 3739)

Victoria, Texas, United States

Velocity Clinical Research - Hampton ( Site 3744)

Hampton, Virginia, United States

Eastside Research Associates ( Site 3727)

Redmond, Washington, United States

CEMIC ( Site 0101)

Buenos Aires., Buenos Aires, Argentina

Hospital Italiano de Buenos Aires ( Site 0107)

Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)

Mar del Plata, Buenos Aires, Argentina

Nefra Medical Care - Moron ( Site 0109)

Morón, Buenos Aires, Argentina

Hospital Felicio Rocho (HFR) - Nucleo de Ciencias da Saude ( Site 0402)

Belo Horizonte, Minas Gerais, Brazil

Instituto Atena de Pesquisa Clinica ( Site 0406)

Natal, Rio Grande do Norte, Brazil

Centro de Pesquisa em Medicina Tropical - CEPEM - Rondonia ( Site 0405)

Porto Velho, Rondônia, Brazil

Centro de Pesquisa Sao Lucas ( Site 0401)

Campinas, São Paulo, Brazil

Centro de Pesquisa Clinica Institucional do HCFMUSP - CPCi ( Site 0403)

São Paulo, Brazil

Medical Center Asclepius ( Site 0506)

Velingrad, Pazardzhik, Bulgaria

Medical Center Zdrave 1 ( Site 0509)

Kozloduy, Vratsa, Bulgaria

Medical Center 'Medconsult' Burgas EOOD ( Site 0510)

Burgas, Bulgaria

Medconsult Pleven - Lovech ( Site 0501)

Lovech, Bulgaria

Medical Center Hera ( Site 0507)

Montana, Bulgaria

MHAT "Dr. Stamen Iliev" Montana-Department of Pulmonology ( Site 0504)

Montana, Bulgaria

Medconsult Pleven ( Site 0503)

Pleven, Bulgaria

DKC V - Plovdiv ( Site 0508)

Plovdiv, Bulgaria

SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD ( Site 0502)

Rousse, Bulgaria

Diagnostic Consultative Center 22 - Sofia ( Site 0500)

Sofia, Bulgaria

Medical Center Hera EOOD ( Site 0505)

Sofia, Bulgaria

Medical Centre Pratia Clinic EOOD ( Site 0511)

Varna, Bulgaria

IPS SURA San Diego ( Site 0806)

Medellín, Antioquia, Colombia

IPS Centro Científico Asistencial S.A.S ( Site 0800)

Barranquilla, Atlántico, Colombia

Clinica Colsanitas - Sede Reina Sofia ( Site 0807)

Bogotá, Bogota D.C., Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0804)

Bogotá, Bogota D.C., Colombia

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0801)

Valledupar, Cesar Department, Colombia

IMAT S.A.S ( Site 0805)

Montería, Departamento de Córdoba, Colombia

Fundación Valle del Lili ( Site 0803)

Cali, Valle del Cauca Department, Colombia

MeVac - Meilahti Vaccine Research Center ( Site 1200)

Helsinki, Uusimaa, Finland

And 127 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (227)