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
Merck Sharp & Dohme LLC
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 chil…
Interventions
- DrugMolnupiravir
Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
- DrugPlacebo
Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
Locations (222)
- Cullman Clinical Trials ( Site 3813)Cullman, Alabama
- Helios Clinical Research ( Site 3826)Paradise Valley, Arizona
- Absolute Clinical Research ( Site 3709)Phoenix, Arizona
- Clinica de Salud del Valle de Salinas ( Site 3825)Castroville, California
- Ascada Health PC dba Ascada Research ( Site 3750)Fullerton, California
- Pacific Clinical Studies ( Site 3827)Los Alamitos, California