A Phase 3 interventional study of Molnupiravir and Placebo in Coronavirus Disease (COVID-19), sponsored by Merck Sharp & Dohme LLC. Completed at 226 sites in 23 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 2,441 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
Drug: Molnupiravir
Participants take placebo Q12H on Days 1 to 5.
Drug: Placebo
Four molnupiravir 200 mg capsules taken by mouth.
Also known as: MK-4482
Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
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
Only eligible participants without confirmed or suspected coronavirus disease 2019 (COVID-19) were enrolled within a 5-day period of the index case's first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result and COVID-19 symptoms onset.
| Milestone | Molnupiravir | Placebo | Index Participants |
|---|---|---|---|
| Started | 768 | 771 | 902 |
| Treated | 763 | 765 | 0 |
| Completed | 750 | 751 | 0 |
| Not completed | 18 | 20 | 902 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 5 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Randomized by mistake without study treatment | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 10 | 11 | 0 |
| Withdrew: Unkown | 6 | 3 | 0 |
| Withdrew: Discotinued per protocol | 0 | 0 | 902 |
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.
| Percentage of Participants | Molnupiravir | Placebo |
|---|---|---|
| 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 | 41 | 54 |
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.
| Participants | Molnupiravir | Placebo |
|---|---|---|
| Percentage of Participants With ≥1 Adverse Event | 94 | 105 |
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.
| Participants | Molnupiravir | Placebo |
|---|---|---|
| Percentage of Participants Discontinuing From Study Therapy Due to AE | 3 | 1 |
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.
| Participants | Molnupiravir | Placebo |
|---|---|---|
| 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 | 78 | 103 |
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.
| Participants | Molnupiravir | Placebo |
|---|---|---|
| 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 | 51 | 65 |
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.
| Participants | Molnupiravir | Placebo |
|---|---|---|
| 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 | 65 | 85 |
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.
| Participants | Molnupiravir | Placebo |
|---|---|---|
| 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 | 35 | 47 |
Collected over Up to Day 29. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-4482 | 0/768 (0%) | 3/763 (0.4%) | 0/763 (0%) |
| Placebo | 1/771 (0.1%) | 2/765 (0.3%) | 0/765 (0%) |
| Event | MK-4482 | Placebo |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 2/763 | 1/765 |
| Femur fractureInjury, poisoning and procedural complications | 1/763 | 0/765 |
| Acute myocardial infarctionCardiac disorders | 0/763 | 1/765 |
| Age, Continuous(years) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| Median | 37.0 ± 15.6 | 37.0 ± 15.5 | 38.0 ± 17.7 | 37.0 ± 15.6 |
| Age, Customized(Participants) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| <18 | 0 | 0 | 76 | 76 |
| Adults (18-49 years) | 563 | 568 | 548 | 1679 |
| From 50 to 64 years | 144 | 141 | 199 | 484 |
| From 65 to 74 years | 35 | 44 | 54 | 133 |
| >=75 years | 26 | 18 | 25 | 69 |
| Sex: Female, Male(Participants) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| Female | 366 | 342 | 541 | 1249 |
| Male | 402 | 429 | 361 | 1192 |
| Ethnicity (NIH/OMB)(Participants) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| Hispanic or Latino | 323 | 340 | 341 | 1004 |
| Not Hispanic or Latino | 445 | 430 | 552 | 1427 |
| Unknown or Not Reported | 0 | 1 | 9 | 10 |
| Race (NIH/OMB)(Participants) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 85 | 90 | 80 | 255 |
| Asian | 48 | 40 | 62 | 150 |
| Native Hawaiian or Other Pacific Islander | 1 | 4 | 2 | 7 |
| Black or African American | 62 | 60 | 77 | 199 |
| White | 453 | 446 | 552 | 1451 |
| More than one race | 119 | 129 | 128 | 376 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
| Stratification Factor at Randomization Collected via IRT: Household Size(Participants) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| <=3 | 269 | 271 | 0 | 540 |
| >=3 | 499 | 500 | 0 | 999 |
| Stratification Factor at Randomization Collected via IRT: Age Group(Participants) | Molnupiravir | Placebo | Index Participants | Total |
|---|---|---|---|---|
| <=60 | 680 | 680 | 0 | 1360 |
| >=60 | 88 | 91 | 0 | 179 |
Showing the first 100 of 226 sites across 23 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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