Trial Outcomes & Findings for Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) (NCT NCT04939428)
NCT ID: NCT04939428
Last Updated: 2024-09-26
Results Overview
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.
COMPLETED
PHASE3
2441 participants
Day 14
2024-09-26
Participant Flow
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.
Index cases were enrolled but did not receive study treatment upon randomization and with the exception of characteristics collected at baseline and optional exploratory swab collection, no other data were collected.Index participants were not followed up for survival and no mortality data were collected per protocol.Index cases were not included in protocol specified outcome measure data collection.
Participant milestones
| Measure |
Molnupiravir
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
Participants were given placebo Q12H on Days 1 to 5.
|
Index Participants
Index case was a participant with documented COVID-19 infection. Index participants were enrolled but did not receive study intervention. Index participants resided in the same household as enrolled participants who received study intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
768
|
771
|
902
|
|
Overall Study
Treated
|
763
|
765
|
0
|
|
Overall Study
COMPLETED
|
750
|
751
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
902
|
Reasons for withdrawal
| Measure |
Molnupiravir
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
Participants were given placebo Q12H on Days 1 to 5.
|
Index Participants
Index case was a participant with documented COVID-19 infection. Index participants were enrolled but did not receive study intervention. Index participants resided in the same household as enrolled participants who received study intervention.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Randomized By Mistake Without Study Treatment
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
0
|
|
Overall Study
Unkown
|
6
|
3
|
0
|
|
Overall Study
Discotinued per protocol
|
0
|
0
|
902
|
Baseline Characteristics
Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
Baseline characteristics by cohort
| Measure |
Molnupiravir
n=768 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=771 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
Index Participants
n=902 Participants
Index case was a participant with documented COVID-19 infection. Index participants were enrolled but did not receive study intervention. Index participants resided in the same household as enrolled participants who received study intervention.
|
Total
n=2441 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 15.6 • n=768 Participants
|
37.0 years
STANDARD_DEVIATION 15.5 • n=771 Participants
|
38.0 years
STANDARD_DEVIATION 17.7 • n=902 Participants
|
37.0 years
STANDARD_DEVIATION 15.6 • n=2441 Participants
|
|
Age, Customized
<18
|
0 Participants
n=768 Participants
|
0 Participants
n=771 Participants
|
76 Participants
n=902 Participants
|
76 Participants
n=2441 Participants
|
|
Age, Customized
Adults (18-49 years)
|
563 Participants
n=768 Participants
|
568 Participants
n=771 Participants
|
548 Participants
n=902 Participants
|
1679 Participants
n=2441 Participants
|
|
Age, Customized
From 50 to 64 years
|
144 Participants
n=768 Participants
|
141 Participants
n=771 Participants
|
199 Participants
n=902 Participants
|
484 Participants
n=2441 Participants
|
|
Age, Customized
From 65 to 74 years
|
35 Participants
n=768 Participants
|
44 Participants
n=771 Participants
|
54 Participants
n=902 Participants
|
133 Participants
n=2441 Participants
|
|
Age, Customized
>=75 years
|
26 Participants
n=768 Participants
|
18 Participants
n=771 Participants
|
25 Participants
n=902 Participants
|
69 Participants
n=2441 Participants
|
|
Sex: Female, Male
Female
|
366 Participants
n=768 Participants
|
342 Participants
n=771 Participants
|
541 Participants
n=902 Participants
|
1249 Participants
n=2441 Participants
|
|
Sex: Female, Male
Male
|
402 Participants
n=768 Participants
|
429 Participants
n=771 Participants
|
361 Participants
n=902 Participants
|
1192 Participants
n=2441 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
323 Participants
n=768 Participants
|
340 Participants
n=771 Participants
|
341 Participants
n=902 Participants
|
1004 Participants
n=2441 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
445 Participants
n=768 Participants
|
430 Participants
n=771 Participants
|
552 Participants
n=902 Participants
|
1427 Participants
n=2441 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=768 Participants
|
1 Participants
n=771 Participants
|
9 Participants
n=902 Participants
|
10 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
85 Participants
n=768 Participants
|
90 Participants
n=771 Participants
|
80 Participants
n=902 Participants
|
255 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=768 Participants
|
40 Participants
n=771 Participants
|
62 Participants
n=902 Participants
|
150 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=768 Participants
|
4 Participants
n=771 Participants
|
2 Participants
n=902 Participants
|
7 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=768 Participants
|
60 Participants
n=771 Participants
|
77 Participants
n=902 Participants
|
199 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
White
|
453 Participants
n=768 Participants
|
446 Participants
n=771 Participants
|
552 Participants
n=902 Participants
|
1451 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
More than one race
|
119 Participants
n=768 Participants
|
129 Participants
n=771 Participants
|
128 Participants
n=902 Participants
|
376 Participants
n=2441 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=768 Participants
|
2 Participants
n=771 Participants
|
1 Participants
n=902 Participants
|
3 Participants
n=2441 Participants
|
|
Stratification Factor at Randomization Collected via IRT: Household Size
<=3
|
269 Participants
n=768 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
271 Participants
n=771 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
0 Participants
Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
540 Participants
n=1539 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
|
Stratification Factor at Randomization Collected via IRT: Household Size
>=3
|
499 Participants
n=768 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
500 Participants
n=771 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
0 Participants
Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
999 Participants
n=1539 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
|
Stratification Factor at Randomization Collected via IRT: Age Group
<=60
|
680 Participants
n=768 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
680 Participants
n=771 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
0 Participants
Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
1360 Participants
n=1539 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
|
Stratification Factor at Randomization Collected via IRT: Age Group
>=60
|
88 Participants
n=768 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
91 Participants
n=771 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
0 Participants
Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
179 Participants
n=1539 Participants • Per protocol study specific charachteristics data was not collected for index cases as no study specific assessments were done.
|
PRIMARY outcome
Timeframe: Day 14Population: 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. Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=630 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=634 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
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 Percentage of Participants
|
54 Percentage of Participants
|
PRIMARY outcome
Timeframe: 29 daysPopulation: Safety Analyses was conducted in the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention. Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=763 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=765 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
Percentage of Participants With ≥1 Adverse Event
|
94 Participants
|
105 Participants
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: Safety Analyses was conducted in the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention. Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=763 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=765 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
Percentage of Participants Discontinuing From Study Therapy Due to AE
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=763 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=764 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
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 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=630 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=634 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
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 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=572 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=589 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
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 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Up to Day 14Population: Index participants were not included in OM analysis per protocol.
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.
Outcome measures
| Measure |
Molnupiravir
n=114 Participants
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=114 Participants
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
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 Participants
|
47 Participants
|
Adverse Events
MK-4482
Placebo
Serious adverse events
| Measure |
MK-4482
n=763 participants at risk
Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
|
Placebo
n=765 participants at risk
Participants were given placebo Q12H on Days 1 to 5.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/763 • Up to Day 29
All cause mortality (ACM) was analyzed in all randomized participants.Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. Per protocol all-cause mortality and AE information was not collected for index cases.
|
0.13%
1/765 • Number of events 1 • Up to Day 29
All cause mortality (ACM) was analyzed in all randomized participants.Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. Per protocol all-cause mortality and AE information was not collected for index cases.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.26%
2/763 • Number of events 2 • Up to Day 29
All cause mortality (ACM) was analyzed in all randomized participants.Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. Per protocol all-cause mortality and AE information was not collected for index cases.
|
0.13%
1/765 • Number of events 1 • Up to Day 29
All cause mortality (ACM) was analyzed in all randomized participants.Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. Per protocol all-cause mortality and AE information was not collected for index cases.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
1/763 • Number of events 1 • Up to Day 29
All cause mortality (ACM) was analyzed in all randomized participants.Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. Per protocol all-cause mortality and AE information was not collected for index cases.
|
0.00%
0/765 • Up to Day 29
All cause mortality (ACM) was analyzed in all randomized participants.Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. Per protocol all-cause mortality and AE information was not collected for index cases.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER