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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 (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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 (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. 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 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

Treatments Being Tested

DRUG

Molnupiravir

Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

DRUG

Placebo

Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Locations (20)

Cullman Clinical Trials ( Site 3813)
Cullman, Alabama, United States
Helios Clinical Research ( Site 3826)
Paradise Valley, Arizona, United States
Absolute Clinical Research ( Site 3709)
Phoenix, Arizona, United States
Clinica de Salud del Valle de Salinas ( Site 3825)
Castroville, California, United States
Ascada Health PC dba Ascada Research ( Site 3750)
Fullerton, California, United States
Pacific Clinical Studies ( Site 3827)
Los Alamitos, California, United States
Valley Clinical Trials, Inc. ( Site 3707)
Northridge, California, United States
FOMAT Medical Research ( Site 3720)
Oxnard, California, United States
Paradigm Clinical Research, LLC ( Site 3785)
San Diego, California, United States
Optimus Medical ( Site 3817)
San Francisco, California, United States
Millennium Clinical Trials ( Site 3758)
Westlake Village, California, United States
Paradigm Clinical Research Centers, Inc ( Site 3718)
Wheat Ridge, Colorado, United States
Encore Medical Research of Boynton Beach ( Site 3701)
Boynton Beach, Florida, United States
Prestige Clinical Research Center ( Site 3722)
Coral Gables, Florida, United States
Indago Research & Health Center, Inc ( Site 3714)
Hialeah, Florida, United States
Prestige Clinical Research ( Site 3830)
Homestead, Florida, United States
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)
Largo, Florida, United States
Clinical Site Partners, LLC dba Flourish Research ( Site 3717)
Leesburg, Florida, United States
Advanced Pulmonary Research Institute ( Site 3781)
Loxahatchee Groves, Florida, United States
Southern Clinical Research ( Site 3773)
Miami, Florida, United States