The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,441
Four molnupiravir 200 mg capsules taken by mouth.
Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
Cahaba Research, Inc. ( Site 2523)
Birmingham, Alabama, United States
The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)
Mesa, Arizona, United States
The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)
Tucson, Arizona, United States
Hope Clinical Research ( Site 2400)
Canoga Park, California, United States
Carbon Health ( Site 2515)
Carlsbad, California, United States
Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline Nasopharyngeal (NP) Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
Percentage of participants who had undetectable SARS-CoV-2 in baseline NP swabs and developed COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 were reported.
Time frame: Day 14
Percentage of Participants With ≥1 Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: 29 days
Percentage of Participants Discontinuing From Study Therapy Due to AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 5 days
Percentage of Participants (Regardless of SARS-CoV-2 in Baseline NP Swabs) Who Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Time frame: Up to Day 14
Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 29
Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. The efficacy analysis population was the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Time frame: Up to Day 29
Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed Detectable SARS-CoV-2 in NP Swabs on or Before Day 14
All participants had NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Time frame: Up to Day 14
Percentage of Participants Who Had Detectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Time frame: Up to Day 14
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UCSF Fresno ( Site 2528)
Fresno, California, United States
ASCADA Research, LLC ( Site 2516)
Fullerton, California, United States
Marvel Clinical Research ( Site 2490)
Huntington Beach, California, United States
National Research Institute ( Site 2452)
Los Angeles, California, United States
Valley Clinical Trials Inc. ( Site 2406)
Northridge, California, United States
...and 216 more locations