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
Phoenix, Arizona 85051
Study Coordinator
623-377-7022
Northridge, California 91325
Study Coordinator
818-280-4220
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
Hialeah, Florida 33012
Study Coordinator
305-825-6588
Miami, Florida 33125
Study Coordinator
844-312-1727
Lawrenceville, Georgia 30046
Study Coordinator
770-696-4541
Union City, Georgia 30291
Study Coordinator
470-317-3604
Fayette, Mississippi 39069
Study Coordinator
607-786-8655
Monroe, North Carolina 28112
Study Coordinator
704-283-7359
Mount Airy, North Carolina 27030
Study Coordinator
336-415-5507
Pearland, Texas 77584
Study Coordinator
281-916-4220
More Details
- NCT ID
- NCT06667700
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC