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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease (COVID-19)

In brief

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.

Key facts

Study ID

NCT06667700

Run by

Merck Sharp & Dohme LLC

People needed

3082

Starts

2024-12-02

Expected to finish

2031-01-26

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Indago Research and Health Center Inc ( Site 3714) — Miami Lakes, Florida, United States (enrolling)
• Combined Research Orlando Phase I-IV ( Site 3797) — Orlando, Florida, United States (enrolling)
• Clinica de Salud del Valle de Salinas ( Site 3825) — Castroville, California, United States (enrolling)
• Panax Clinical Research ( Site 3803) — Miami Lakes, Florida, United States (enrolling)
• Pacific Clinical Studies ( Site 3827) — Los Alamitos, California, United States (enrolling)
• Valley Clinical Trials, Inc. ( Site 3707) — Northridge, California, United States (enrolling)
• FOMAT Medical Research ( Site 3720) — Oxnard, California, United States (enrolling)
• Paradigm Clinical Research, LLC ( Site 3785) — San Diego, California, United States (enrolling)
• Optimus Medical ( Site 3817) — San Francisco, California, United States (enrolling)
• Helios Clinical Research ( Site 3826) — Paradise Valley, Arizona, United States (enrolling)
• Paradigm Clinical Research Centers, Inc ( Site 3718) — Wheat Ridge, Colorado, United States (enrolling)
• Encore Medical Research of Boynton Beach ( Site 3701) — Boynton Beach, Florida, United States (enrolling)
• Prestige Clinical Research Center ( Site 3722) — Coral Gables, Florida, United States (enrolling)
• Prestige Clinical Research ( Site 3830) — Homestead, Florida, United States (enrolling)
• Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779) — Largo, Florida, United States (enrolling)
• Clinical Site Partners, LLC dba Flourish Research ( Site 3717) — Leesburg, Florida, United States (enrolling)
• Advanced Pulmonary Research Institute ( Site 3781) — Loxahatchee Groves, Florida, United States (enrolling)
• Southern Clinical Research ( Site 3773) — Miami, Florida, United States (enrolling)
• Florida Pharmaceutical Research and Associates ( Site 3763) — Miami, Florida, United States (enrolling)
• Bio-Medical Research LLC ( Site 3804) — Miami, Florida, United States (enrolling)
• Millennium Clinical Trials ( Site 3758) — Westlake Village, California, United States (enrolling)
• Miami Clinical Research ( Site 3729) — Miami, Florida, United States (enrolling)
• Reed Medical Research ( Site 3761) — Miami, Florida, United States (enrolling)
• Palm Springs Community Health Center ( Site 3757) — Miami Lakes, Florida, United States (enrolling)
• CDC Research Institute ( Site 3716) — Port Saint Lucie, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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