Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19 (NCT 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

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

Reasons for withdrawal
Measure	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	1	1	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Subject	1	1	0
Overall Study Randomized not dosed	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

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=5 Participants	42.4 years STANDARD_DEVIATION 14.88 • n=7 Participants	42.2 years STANDARD_DEVIATION 14.36 • n=5 Participants	39.7 years STANDARD_DEVIATION 14.10 • n=4 Participants	40.8 years STANDARD_DEVIATION 14.57 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	32 Participants n=7 Participants	27 Participants n=5 Participants	34 Participants n=4 Participants	104 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	28 Participants n=4 Participants	98 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	23 Participants n=7 Participants	33 Participants n=5 Participants	23 Participants n=4 Participants	86 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	39 Participants n=7 Participants	21 Participants n=5 Participants	39 Participants n=4 Participants	115 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	56 Participants n=7 Participants	49 Participants n=5 Participants	54 Participants n=4 Participants	176 Participants n=21 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days

Population: mITT - modified Intent to Treat Population

Outcome measures

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 days

Population: 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

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 days

Population: 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

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 days

Population: 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

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

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
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
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

Other adverse events

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

Dr. Wendy Painter

Ridgeback Biotherapeutics

Phone: 786-687-2495

Email: [email protected]

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