NCT06667700From ClinicalTrials.govRecruiting

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

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

Coronavirus Disease (COVID-19)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Merck Sharp & Dohme LLC
Enrolment target: 3,082
Started: 2 December 2024
Main results due: 26 January 2031
Study sites: 224
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(224)

Cullman Clinical Trials ( Site 3813)
Cullman, Alabama, United States
Completed
Helios Clinical Research ( Site 3826)
Paradise Valley, Arizona, United States
Recruiting
Absolute Clinical Research ( Site 3709)
Phoenix, Arizona, United States
Completed
Clinica de Salud del Valle de Salinas ( Site 3825)
Castroville, California, United States
Recruiting
Ascada Health PC dba Ascada Research ( Site 3750)
Fullerton, California, United States
Completed
Pacific Clinical Studies ( Site 3827)
Los Alamitos, California, United States
Recruiting
Valley Clinical Trials, Inc. ( Site 3707)
Northridge, California, United States
Recruiting
FOMAT Medical Research ( Site 3720)
Oxnard, California, United States
Recruiting
Paradigm Clinical Research, LLC ( Site 3785)
San Diego, California, United States
Recruiting
Optimus Medical ( Site 3817)
San Francisco, California, United States
Recruiting
Millennium Clinical Trials ( Site 3758)
Westlake Village, California, United States
Recruiting
Paradigm Clinical Research Centers, Inc ( Site 3718)
Wheat Ridge, Colorado, United States
Recruiting
Encore Medical Research of Boynton Beach ( Site 3701)
Boynton Beach, Florida, United States
Recruiting
Prestige Clinical Research Center ( Site 3722)
Coral Gables, Florida, United States
Recruiting
Prestige Clinical Research ( Site 3830)
Homestead, Florida, United States
Recruiting
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)
Largo, Florida, United States
Recruiting
Clinical Site Partners, LLC dba Flourish Research ( Site 3717)
Leesburg, Florida, United States
Recruiting
Advanced Pulmonary Research Institute ( Site 3781)
Loxahatchee Groves, Florida, United States
Active, not recruiting
Southern Clinical Research ( Site 3773)
Miami, Florida, United States
Recruiting
Florida Pharmaceutical Research and Associates ( Site 3763)
Miami, Florida, United States
Recruiting
Bio-Medical Research LLC ( Site 3804)
Miami, Florida, United States
Recruiting
Bright Research Center ( Site 3746)
Miami, Florida, United States
Completed
Miami Clinical Research ( Site 3729)
Miami, Florida, United States
Recruiting
Reed Medical Research ( Site 3761)
Miami, Florida, United States
Recruiting
Palm Springs Community Health Center ( Site 3757)
Miami Lakes, Florida, United States
Recruiting
Panax Clinical Research ( Site 3803)
Miami Lakes, Florida, United States
Recruiting
Indago Research and Health Center Inc ( Site 3714)
Miami Lakes, Florida, United States
Recruiting
Combined Research Orlando Phase I-IV ( Site 3797)
Orlando, Florida, United States
Recruiting
CDC Research Institute ( Site 3716)
Port Saint Lucie, Florida, United States
Recruiting
New Tampa Health ( Site 3764)
Tampa, Florida, United States
Recruiting
Clinical Research Trials of Florida ( Site 3703)
Tampa, Florida, United States
Recruiting
Precision Research Center ( Site 3704)
Tampa, Florida, United States
Recruiting
Encore Medical Research - Weston ( Site 3708)
Weston, Florida, United States
Completed
Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)
Lawrenceville, Georgia, United States
Recruiting
Renew Health Clinical Research ( Site 3760)
Snellville, Georgia, United States
Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)
Union City, Georgia, United States
Completed
Paradigm Clinical Research - Boise ( Site 3841)
Boise, Idaho, United States
Completed
Rush University Medical Center ( Site 3748)
Chicago, Illinois, United States
Recruiting
Duly Health and Care ( Site 3799)
Lombard, Illinois, United States
Recruiting
University of Louisville School of Medicine ( Site 3706)
Louisville, Kentucky, United States
Recruiting
Barnum Medical Research ( Site 3828)
Natchitoches, Louisiana, United States
Completed
Annapolis Internal Medicine - CCT Research ( Site 3700)
Annapolis, Maryland, United States
Recruiting
Kur Research - Columbia Medical ( Site 3767)
Columbia, Maryland, United States
Recruiting
Revival Research Institute, LLC ( Site 3835)
Dearborn, Michigan, United States
Completed
Michigan Center of Medical Research (MICHMER) ( Site 3734)
Farmington Hills, Michigan, United States
Completed
Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)
Grosse Pointe Woods, Michigan, United States
Recruiting
Mankato Clinic ( Site 3842)
Mankato, Minnesota, United States
Recruiting
Prime Health and Wellness/SKYCRNG ( Site 3726)
Fayette, Mississippi, United States
Recruiting
SKY Integrative Medical Center/SKYCRNG ( Site 3740)
Ridgeland, Mississippi, United States
Recruiting
Nevada Health Centers ( Site 3840)
Carson City, Nevada, United States
Recruiting
WR-CRCN, LLC ( Site 3818)
Las Vegas, Nevada, United States
Recruiting
Saint Michael's Medical Center ( Site 3808)
Newark, New Jersey, United States
Recruiting
Holy Name Medical Center ( Site 3807)
Teaneck, New Jersey, United States
Recruiting
Weill Cornell Medical College ( Site 3814)
New York, New York, United States
Recruiting
Prime Global Research ( Site 3731)
The Bronx, New York, United States
Recruiting
OnSite Clinical Solutions ( Site 3784)
Charlotte, North Carolina, United States
Recruiting
Monroe Biomedical Research ( Site 3732)
Monroe, North Carolina, United States
Recruiting
IMA Clinical Research Mount Airy ( Site 3745)
Mount Airy, North Carolina, United States
Recruiting
Research Innovations, LLC ( Site 3712)
Beavercreek, Ohio, United States
Active, not recruiting
Midlands Neurology & Pain Associates ( Site 3751)
Columbia, South Carolina, United States
Active, not recruiting

Showing 60 of 224 sites — filter to narrow it down. 200 of the 224 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06667700. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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