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RecruitingPhase 3

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

Merck Sharp & Dohme LLC · NCT06667700

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
3082
US sites recruiting
55
Study start
December 2, 2024
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Molnupiravir; Placebo

Conditions: Coronavirus Disease (COVID-19)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Helios Clinical Research ( Site 3826)

    Paradise Valley, AZ 85253

    Site contact: Study Coordinator · 480-659-0448

  • Clinica de Salud del Valle de Salinas ( Site 3825)

    Castroville, CA 95012

    Site contact: Study Coordinator · 805-483-1185

  • Pacific Clinical Studies ( Site 3827)

    Los Alamitos, CA 90720

    Site contact: Study Coordinator · 5625980600x205

  • Valley Clinical Trials, Inc. ( Site 3707)

    Northridge, CA 91325

    Site contact: Study Coordinator · 818-280-4220

  • FOMAT Medical Research ( Site 3720)

    Oxnard, CA 93030

    Site contact: Study Coordinator · 805-483-1185

  • Paradigm Clinical Research, LLC ( Site 3785)

    San Diego, CA 91208

    Site contact: Study Coordinator · 858274426

  • Optimus Medical ( Site 3817)

    San Francisco, CA 94102

    Site contact: Study Coordinator · 415-518-1292

  • Millennium Clinical Trials ( Site 3758)

    Westlake Village, CA 91361

    Site contact: Study Coordinator · 805-496-3322

  • Paradigm Clinical Research Centers, Inc ( Site 3718)

    Wheat Ridge, CO 80033

    Site contact: Study Coordinator · 303-463-1947

  • Encore Medical Research of Boynton Beach ( Site 3701)

    Boynton Beach, FL 33436

    Site contact: Study Coordinator · 561-774-8799

  • Prestige Clinical Research Center ( Site 3722)

    Coral Gables, FL 33134

    Site contact: Study Coordinator · 305-907-6960

  • Prestige Clinical Research ( Site 3830)

    Homestead, FL 33030

    Site contact: Study Coordinator · 305-907-6961

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

    Largo, FL 33777

    Site contact: Study Coordinator · 727-347-8839

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

    Leesburg, FL 34748

    Site contact: Study Coordinator · 325-435-7240

  • Southern Clinical Research ( Site 3773)

    Miami, FL 33125

    Site contact: Study Coordinator · 844-312-1727

  • Florida Pharmaceutical Research and Associates ( Site 3763)

    Miami, FL 33143

    Site contact: Study Coordinator · 786-254-7296

  • Bio-Medical Research LLC ( Site 3804)

    Miami, FL 33144

    Site contact: Study Coordinator · 305-671-3686

  • Miami Clinical Research ( Site 3729)

    Miami, FL 33155

    Site contact: Study Coordinator · 305-433-6496

  • Reed Medical Research ( Site 3761)

    Miami, FL 33176

    Site contact: Study Coordinator · 305-413-0531

  • Palm Springs Community Health Center ( Site 3757)

    Miami Lakes, FL 33014

    Site contact: Study Coordinator · 786-334-6675

  • Panax Clinical Research ( Site 3803)

    Miami Lakes, FL 33014

    Site contact: Study Coordinator · 305-698-4500

  • Indago Research and Health Center Inc ( Site 3714)

    Miami Lakes, FL 33016

    Site contact: Study Coordinator · 305-825-6588

  • Combined Research Orlando Phase I-IV ( Site 3797)

    Orlando, FL 32807

    Site contact: Study Coordinator · 407-440-4493

  • CDC Research Institute ( Site 3716)

    Port Saint Lucie, FL 34952

    Site contact: Study Coordinator · 772-807-1636

  • New Tampa Health ( Site 3764)

    Tampa, FL 33603

    Site contact: Study Coordinator · 813-440-6355

  • Clinical Research Trials of Florida ( Site 3703)

    Tampa, FL 33607

    Site contact: Study Coordinator · 813-873-8102

  • Precision Research Center ( Site 3704)

    Tampa, FL 33614

    Site contact: Study Coordinator · 813-513-2365

  • Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)

    Lawrenceville, GA 30046

    Site contact: Study Coordinator · 770-696-4541

  • Renew Health Clinical Research ( Site 3760)

    Snellville, GA 30078

    Site contact: Study Coordinator · 706-223-3560

  • Rush University Medical Center ( Site 3748)

    Chicago, IL 60612

    Site contact: Study Coordinator · 312-942-5987

  • Duly Health and Care ( Site 3799)

    Lombard, IL 60148

    Site contact: Study Coordinator · 630-545-7760

  • University of Louisville School of Medicine ( Site 3706)

    Louisville, KY 40202

    Site contact: Study Coordinator · 502-852-3836

  • Annapolis Internal Medicine - CCT Research ( Site 3700)

    Annapolis, MD 21401

    Site contact: Study Coordinator · 410-824-1005

  • Kur Research - Columbia Medical ( Site 3767)

    Columbia, MD 21045

    Site contact: Study Coordinator · 410-964-8522

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

    Grosse Pointe Woods, MI 48236

    Site contact: Study Coordinator · 313-343-6311

  • Mankato Clinic ( Site 3842)

    Mankato, MN 56001

    Site contact: Study Coordinator · 507-625-1811

  • SKY Integrative Medical Center/SKYCRNG ( Site 3740)

    Ridgeland, MS 39157

    Site contact: Study Coordinator · 601-617-7717

  • Nevada Health Centers ( Site 3840)

    Carson City, NV 89706

    Site contact: Study Coordinator · 770-200-9775

  • WR-CRCN, LLC ( Site 3818)

    Las Vegas, NV 89106

    Site contact: Study Coordinator · 702-893-8968

  • Saint Michael's Medical Center ( Site 3808)

    Newark, NJ 07102

    Site contact: Study Coordinator · 973-877-5162

  • Holy Name Medical Center ( Site 3807)

    Teaneck, NJ 07666

    Site contact: Study Coordinator · 201-833-3000

  • Weill Cornell Medical College ( Site 3814)

    New York, NY 10065

    Site contact: Study Coordinator · 212-746-7587

  • Prime Global Research ( Site 3731)

    The Bronx, NY 10456

    Site contact: Study Coordinator · 718-676-9444

  • OnSite Clinical Solutions ( Site 3784)

    Charlotte, NC 28277

    Site contact: Study Coordinator · 800-785-3150

  • Monroe Biomedical Research ( Site 3732)

    Monroe, NC 28112

    Site contact: Study Coordinator · 704-283-7359

  • IMA Clinical Research Mount Airy ( Site 3745)

    Mount Airy, NC 27030

    Site contact: Study Coordinator · 336-415-5507

  • Helios Clinical Research - JAC ( Site 3833)

    Jackson, TN 38305

    Site contact: Study Coordinator · 731-431-5027

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

    Conroe, TX 77384

    Site contact: Study Coordinator · 281-639-5061

  • South Texas Clinical Research ( Site 3815)

    Corpus Christi, TX 78404

    Site contact: Study Coordinator · 361-288-4668

  • Houston Methodist Hospital ( Site 3800)

    Houston, TX 77030

    Site contact: Study Coordinator · 713-441-3250

  • MD Anderson ( Site 3843)

    Houston, TX 77030

    Site contact: Study Coordinator · 713-792-6830

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

    Laredo, TX 78041

    Site contact: Study Coordinator · 956-307-4280

  • LinQ Research ( Site 3824)

    Pearland, TX 77584

    Site contact: Study Coordinator · 281-916-4220

  • Crossroads Clinical Research-Family Practice ( Site 3739)

    Victoria, TX 77901

    Site contact: Study Coordinator · 361-574-7800

  • Eastside Research Associates ( Site 3727)

    Redmond, WA 98052

    Site contact: Study Coordinator · 425-869-6828

Study contacts (from the official record)

  • Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
A Clinical Study of Molnupiravir to Prevent Severe Illness From… (NCT06667700) | Bored Studies