Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19 (NCT NCT04405570)
NCT ID: NCT04405570
Last Updated: 2022-02-16
Results Overview
The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test. Non detectable defined as "a viral load below the limit of quantification
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
28 days
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
Molnupiravir 200 mg
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
molnupiravir twice daily (BID) for 5 days
|
Placebo
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
64
|
55
|
62
|
|
Overall Study
Number of Subjects Randomized Not Dosed
|
0
|
2
|
0
|
0
|
|
Overall Study
Number of Subjects in the Safety Population
|
23
|
62
|
55
|
62
|
|
Overall Study
Number of Subjects in the mITT Population
|
23
|
61
|
53
|
61
|
|
Overall Study
COMPLETED
|
23
|
59
|
52
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
3
|
1
|
Reasons for withdrawal
| Measure |
Molnupiravir 200 mg
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
molnupiravir twice daily (BID) for 5 days
|
Placebo
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Randomized not dosed
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19
Baseline characteristics by cohort
| Measure |
Molnupiravir 200 mg
n=23 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=62 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=55 Participants
molnupiravir twice daily (BID) for 5 days
|
Placebo
n=62 Participants
Placebo twice daily (BID) for 5 days
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 15.34 • n=99 Participants
|
42.4 years
STANDARD_DEVIATION 14.88 • n=107 Participants
|
42.2 years
STANDARD_DEVIATION 14.36 • n=206 Participants
|
39.7 years
STANDARD_DEVIATION 14.10 • n=157 Participants
|
40.8 years
STANDARD_DEVIATION 14.57 • n=390 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
34 Participants
n=157 Participants
|
104 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
28 Participants
n=157 Participants
|
98 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
23 Participants
n=157 Participants
|
86 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
39 Participants
n=157 Participants
|
115 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
11 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
54 Participants
n=157 Participants
|
176 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: mITT - modified Intent to Treat Population
The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test. Non detectable defined as "a viral load below the limit of quantification
Outcome measures
| Measure |
Molnupiravir 200 mg
n=23 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=61 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=53 Participants
molnupiravir twice daily (BID) for 5 days
|
Placebo
n=61 Participants
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
Number (%) with response
|
21 Participants
|
48 Participants
|
49 Participants
|
49 Participants
|
|
Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
Number (%) censored
|
2 Participants
|
13 Participants
|
4 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: mITT - modified Intent to Treat Population
The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test. Non detectable defined as "a viral load below the limit of quantification
Outcome measures
| Measure |
Molnupiravir 200 mg
n=23 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=61 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=53 Participants
molnupiravir twice daily (BID) for 5 days
|
Placebo
n=61 Participants
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs
|
22.0 Days
Interval 15.0 to 28.0
|
27.0 Days
Interval 15.0 to 28.0
|
14.0 Days
Interval 13.0 to 14.0
|
15.0 Days
Interval 15.0 to 27.0
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Safety population
1\) any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.
Outcome measures
| Measure |
Molnupiravir 200 mg
n=23 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=62 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=55 Participants
molnupiravir twice daily (BID) for 5 days
|
Placebo
n=62 Participants
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
AEs leading to early discontinuation of blinded treatment (active or placebo)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
AEs leading to study drug-related discontinuation of treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
new grade 3 or higher AEs (not already present at baseline)
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
study drug-related new grade 3 or higher AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety population
Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.
Outcome measures
| Measure |
Molnupiravir 200 mg
n=23 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=62 Participants
molnupiravir twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=55 Participants
molnupiravir twice daily (BID) for 5 days
|
Placebo
n=62 Participants
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher
|
5 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
Adverse Events
Molnupiravir 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Molnupiravir 400 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Molnupiravir 800 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Molnupiravir 200 mg
n=23 participants at risk
EIDD-2801 twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=62 participants at risk
EIDD-2801 twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=55 participants at risk
EIDD-2801 twice daily (BID) for 5 days
|
Placebo
n=62 participants at risk
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/23 • 28 days
|
1.6%
1/62 • Number of events 1 • 28 days
|
0.00%
0/55 • 28 days
|
0.00%
0/62 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/23 • 28 days
|
0.00%
0/62 • 28 days
|
1.8%
1/55 • Number of events 1 • 28 days
|
0.00%
0/62 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • 28 days
|
0.00%
0/62 • 28 days
|
0.00%
0/55 • 28 days
|
1.6%
1/62 • Number of events 1 • 28 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • 28 days
|
1.6%
1/62 • Number of events 1 • 28 days
|
0.00%
0/55 • 28 days
|
0.00%
0/62 • 28 days
|
Other adverse events
| Measure |
Molnupiravir 200 mg
n=23 participants at risk
EIDD-2801 twice daily (BID) for 5 days
|
Molnupiravir 400 mg
n=62 participants at risk
EIDD-2801 twice daily (BID) for 5 days
|
Molnupiravir 800 mg
n=55 participants at risk
EIDD-2801 twice daily (BID) for 5 days
|
Placebo
n=62 participants at risk
Placebo twice daily (BID) for 5 days
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2 • 28 days
|
1.6%
1/62 • Number of events 3 • 28 days
|
0.00%
0/55 • 28 days
|
0.00%
0/62 • 28 days
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Number of events 2 • 28 days
|
1.6%
1/62 • Number of events 1 • 28 days
|
1.8%
1/55 • Number of events 1 • 28 days
|
6.5%
4/62 • Number of events 4 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is requested to obtain written consent from the Sponsor before anything relating to the study can be published.
- Publication restrictions are in place
Restriction type: OTHER