A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Purpose
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.
Condition
- Coronavirus Disease (COVID-19)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Molnupiravir |
Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses) |
|
|
Placebo Comparator Placebo |
Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses) |
|
Recruiting Locations
Cullman, Alabama 35055
Study Coordinator
888-577-8839
Paradise Valley, Arizona 85253
Study Coordinator
480-659-0448
Phoenix, Arizona 85051
Study Coordinator
888-577-8839
Castroville, California 95012
Study Coordinator
805-483-1185
Fullerton, California 92835
Study Coordinator
888-577-8839
Los Alamitos, California 90720
Study Coordinator
5625980600x205
Northridge, California 91325
Study Coordinator
888-577-8839
Oxnard, California 93030
Study Coordinator
805-483-1185
San Diego, California 91208
Study Coordinator
858274426
San Francisco, California 94102
Study Coordinator
415-518-1292
Westlake Village, California 91361
Study Coordinator
805-496-3322
Wheat Ridge, Colorado 80033
Study Coordinator
303-463-1947
Boynton Beach, Florida 33436
Study Coordinator
561-774-8799
Coral Gables, Florida 33134
Study Coordinator
305-907-6960
Hialeah, Florida 33012
Study Coordinator
305-825-6588
Homestead, Florida 33030
Study Coordinator
305-907-6961
Largo, Florida 33777
Study Coordinator
727-347-8839
Leesburg, Florida 34748
Study Coordinator
325-435-7240
Loxahatchee Groves, Florida 33470
Study Coordinator
561-795-1022
Miami Lakes, Florida 33014
Study Coordinator
888-577-8839
Miami Lakes, Florida 33014
Study Coordinator
305-698-4500
Miami, Florida 33125
Study Coordinator
888-577-8839
Miami, Florida 33143
Study Coordinator
786-254-7296
Miami, Florida 33144
Study Coordinator
888-577-8839
Miami, Florida 33144
Study Coordinator
888-577-8839
Miami, Florida 33155
Study Coordinator
888-577-8839
Miami, Florida 33176
Study Coordinator
305-413-0531
Orlando, Florida 32807
Study Coordinator
407-440-4493
Port Saint Lucie, Florida 34952
Study Coordinator
888-577-8839
Tampa, Florida 33603
Study Coordinator
813-440-6355
Tampa, Florida 33607
Study Coordinator
888-577-8839
Tampa, Florida 33614
Study Coordinator
813-513-2365
Weston, Florida 33331
Study Coordinator
888-577-8839
Lawrenceville, Georgia 30046
Study Coordinator
770-696-4541
Snellville, Georgia 30078
Study Coordinator
888-577-8839
Union City, Georgia 30291
Study Coordinator
470-317-3604
Boise, Idaho 83709
Study Coordinator
208-801-7440
Louisville, Kentucky 40202
Study Coordinator
888-577-8839
Natchitoches, Louisiana 71457
Study Coordinator
318-352-9880
Annapolis, Maryland 21401
Study Coordinator
888-577-8839
Columbia, Maryland 21045
Study Coordinator
410-964-8522
Dearborn, Michigan 48126
Study Coordinator
888-577-8839
Farmington Hills, Michigan 48334
Study Coordinator
248-747-4383
Grosse Pointe Woods, Michigan 48236
Study Coordinator
888-577-8839
Mankato, Minnesota 56001
Study Coordinator
507-625-1811
Fayette, Mississippi 39069
Study Coordinator
888-577-8839
Ridgeland, Mississippi 39157
Study Coordinator
888-577-8839
Carson City, Nevada 89706
Study Coordinator
770-200-9775
Las Vegas, Nevada 89106
Study Coordinator
702-893-8968
Teaneck, New Jersey 07666
Study Coordinator
201-833-3000
Bronx, New York 10456
Study Coordinator
718-676-9444
New York, New York 10065
Study Coordinator
888-577-8839
Charlotte, North Carolina 28277
Study Coordinator
888-577-8839
Monroe, North Carolina 28112
Study Coordinator
888-577-8839
Mount Airy, North Carolina 27030
Study Coordinator
336-415-5507
Beavercreek, Ohio 45431
Study Coordinator
937-986-1851
Columbia, South Carolina 29205
Study Coordinator
888-577-8839
Jackson, Tennessee 38305
Study Coordinator
731-431-5027
Conroe, Texas 77384
Study Coordinator
281-639-5061
Corpus Christi, Texas 78404
Study Coordinator
888-577-8839
Forney, Texas 75126
Study Coordinator
9725640044x240
Laredo, Texas 78041
Study Coordinator
956-307-4280
Pearland, Texas 77584
Study Coordinator
281-916-4220
Victoria, Texas 77901
Study Coordinator
361-574-7800
Redmond, Washington 98052
Study Coordinator
425-869-6828
Humacao, Puerto Rico 00791
Study Coordinator
1-888-577-8839
San Juan, Puerto Rico 00921
Study Coordinator
1-888-577-8839
San Juan, Puerto Rico 00926
Study Coordinator
1-888-577-8839
More Details
- NCT ID
- NCT06667700
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC