Study

Overview

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

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 Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

3082

Study Start Date:

December 2024

Estimated Study Completion Date:

January 2031

Estimated Primary Completion Date:

January 2031

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

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 ≥35, diabetes)
Is unable 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 renal or hepatic impairment
- Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
- Has uncontrolled HIV infection
- Has known or suspected NMV/r resistance
- NMV/r is not approved/authorized in the participant’s country or it is not accessible to participant (e.g., drug shortage)

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 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
- Is receiving >4 liters/minute supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2
Has received a COVID-19 vaccine within 30 days prior to randomization
Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization
Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Locations

United States Toll Free Number 1-800-770-4674

Humacao, 00791
San Juan, 00921
San Juan, 00926
Cullman, Alabama, 35055
Paradise Valley, Arizona, 85253
Phoenix, Arizona, 85051
Castroville, California, 95012
Fullerton, California, 92835
Los Alamitos, California, 90720
Northridge, California, 91325
Oxnard, California, 93030
San Diego, California, 91208
San Francisco, California, 94102
Westlake Village, California, 91361
Wheat Ridge, Colorado, 80033
Boynton Beach, Florida, 33436
Coral Gables, Florida, 33134
Hialeah, Florida, 33012
Homestead, Florida, 33030
Largo, Florida, 33777
Leesburg, Florida, 34748
Loxahatchee, Florida, 33470
Miami, Florida, 33125
Miami, Florida, 33143
Miami, Florida, 33144
Miami, Florida, 33144
Miami, Florida, 33155
Miami, Florida, 33176
Miami Lakes, Florida, 33014
Miami Lakes, Florida, 33014
Orlando, Florida, 32807
Port St. Lucie, Florida, 34952
Tampa, Florida, 33603
Tampa, Florida, 33607
Tampa, Florida, 33614
Weston, Florida, 33331
Lawrenceville, Georgia, 30046
Snellville, Georgia, 30078
Union City, Georgia, 30291
Boise, Idaho, 83709
Louisville, Kentucky, 40202
NATCHITOCHES, Louisiana, 71457
Annapolis, Maryland, 21401
Columbia, Maryland, 21045
Dearborn, Michigan, 48126
Farmington Hills, Michigan, 48334
Grosse Pointe Woods, Michigan, 48236
Mankato, Minnesota, 56001
Fayette, Mississippi, 39069
Ridgeland, Mississippi, 39157
Carson City, Nevada, 89706
Las Vegas, Nevada, 89106
Teaneck, New Jersey, 07666
Bronx, New York, 10456
New York, New York, 10065
Charlotte, North Carolina, 28277
Monroe, North Carolina, 28112
Mount Airy, North Carolina, 27030
Beavercreek, Ohio, 45431
Columbia, South Carolina, 29205
Jackson, Tennessee, 38305
Conroe, Texas, 77384
Corpus Christi, Texas, 78404
Forney, Texas, 75126
Laredo, Texas, 78041
Pearland, Texas, 77584
Victoria, Texas, 77901
Redmond, Washington, 98052

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results