Trial Outcomes & Findings for The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID) (NCT NCT04405739)

Last Updated: 2023-03-23

Results Overview

Achievement of undetectable (below the limit of detection of the assay) SARS-CoV-2 RNA by day 5 in NP swabs by quantitative Polymerase Chain Reaction (qPCR) in the Efficacy Analysis Set (EAS). The Efficacy Analysis Set consisted of all participants treated with at least on dose of study drug and with at least 1 post baseline assessment of SARS-CoV-2 RNA in NP swabs by qPCR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

28 days

Results posted on

2023-03-23

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	4	18	25	24
Overall Study COMPLETED	4	13	22	18
Overall Study NOT COMPLETED	0	5	3	6

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	0	0
Overall Study Lost to Follow-up	2	1	3
Overall Study Withdrawal by Subject	2	1	1
Overall Study Death	0	1	0
Overall Study Transferred to rehab	0	0	1
Overall Study Pt. refused IP after 1 dose	0	0	1

Baseline Characteristics

Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Molnupiravir 200 mg n=4 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 400 mg n=18 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 800 mg n=25 Participants molnupiravir twice daily (BID) for 5 days	Placebo n=24 Participants molnupiravir twice daily (BID) for 5 days	Total n=71 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 9.07 • n=4 Participants	52.1 years STANDARD_DEVIATION 16.37 • n=18 Participants	53.5 years STANDARD_DEVIATION 15.42 • n=25 Participants	57.1 years STANDARD_DEVIATION 14.43 • n=24 Participants	54.5 years STANDARD_DEVIATION 14.93 • n=71 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	6 Participants n=18 Participants	11 Participants n=25 Participants	11 Participants n=24 Participants	28 Participants n=71 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	12 Participants n=18 Participants	14 Participants n=25 Participants	13 Participants n=24 Participants	43 Participants n=71 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=4 Participants	10 Participants n=18 Participants	11 Participants n=25 Participants	8 Participants n=24 Participants	30 Participants n=71 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=4 Participants	8 Participants n=18 Participants	14 Participants n=25 Participants	16 Participants n=24 Participants	41 Participants n=71 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=18 Participants	0 Participants n=25 Participants	0 Participants n=24 Participants	0 Participants n=71 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=18 Participants	0 Participants n=25 Participants	0 Participants n=24 Participants	0 Participants n=71 Participants
Race/Ethnicity, Customized Asian	0 Participants n=4 Participants	0 Participants n=18 Participants	2 Participants n=25 Participants	1 Participants n=24 Participants	3 Participants n=71 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=4 Participants	2 Participants n=18 Participants	7 Participants n=25 Participants	4 Participants n=24 Participants	15 Participants n=71 Participants
Race/Ethnicity, Customized White	1 Participants n=4 Participants	7 Participants n=18 Participants	12 Participants n=25 Participants	14 Participants n=24 Participants	34 Participants n=71 Participants
Race/Ethnicity, Customized Unknown/Not reported	0 Participants n=4 Participants	1 Participants n=18 Participants	0 Participants n=25 Participants	1 Participants n=24 Participants	2 Participants n=71 Participants
Race/Ethnicity, Customized Other	1 Participants n=4 Participants	7 Participants n=18 Participants	3 Participants n=25 Participants	4 Participants n=24 Participants	15 Participants n=71 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=4 Participants	1 Participants n=18 Participants	1 Participants n=25 Participants	0 Participants n=24 Participants	2 Participants n=71 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=18 Participants	0 Participants n=25 Participants	0 Participants n=24 Participants	0 Participants n=71 Participants
SARS-CoV-2 RNA by qPCR in NP Swabs	6.45 log 10 copies/mL STANDARD_DEVIATION 1.655 • n=4 Participants • Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.	4.83 log 10 copies/mL STANDARD_DEVIATION 1.487 • n=15 Participants • Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.	4.77 log 10 copies/mL STANDARD_DEVIATION 1.442 • n=23 Participants • Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.	5.07 log 10 copies/mL STANDARD_DEVIATION 1.553 • n=20 Participants • Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.	5.24 log 10 copies/mL STANDARD_DEVIATION 0.42 • n=62 Participants • Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.

PRIMARY outcome

Timeframe: 28 days

Population: EAS Population

Outcome measures

Outcome measures
Measure	Molnupiravir 200 mg n=4 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 400 mg n=16 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 800 mg n=25 Participants molnupiravir twice daily (BID) for 5 days	Placebo n=24 Participants Placebo twice daily (BID) for 5 days
Number of Participants That Achieve Virologic Clearance After Oral Administration of EIDD-2801	0 Participants	4 Participants	10 Participants	7 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Population

Incidence of Serious Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS in the Safety Population, defined as all participants treated with at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Molnupiravir 200 mg n=4 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 400 mg n=18 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 800 mg n=25 Participants molnupiravir twice daily (BID) for 5 days	Placebo n=24 Participants Placebo twice daily (BID) for 5 days
Number of Participants With Any Serious Adverse Events(SAEs) as Assessed by DAIDS	0 Participants	0 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Population

Incidence of Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS

Outcome measures

Outcome measures
Measure	Molnupiravir 200 mg n=4 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 400 mg n=18 Participants molnupiravir twice daily (BID) for 5 days	Molnupiravir 800 mg n=25 Participants molnupiravir twice daily (BID) for 5 days	Placebo n=24 Participants Placebo twice daily (BID) for 5 days
Number of Participants With Any Adverse Events(AEs) as Assessed by DAIDS	4 Participants	11 Participants	12 Participants	15 Participants

Adverse Events

Molnupiravir 200 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Molnupiravir 400 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Molnupiravir 800 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Placebo

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Molnupiravir 200 mg n=4 participants at risk molnupiravir twice daily (BID) for 5 days	Molnupiravir 400 mg n=18 participants at risk molnupiravir twice daily (BID) for 5 days	Molnupiravir 800 mg n=25 participants at risk molnupiravir twice daily (BID) for 5 days	Placebo n=24 participants at risk Placebo twice daily (BID) for 5 days
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/4 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/18 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	4.0% 1/25 • Number of events 1 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/24 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.
Vascular disorders Hypovolemic shock	0.00% 0/4 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/18 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	4.0% 1/25 • Number of events 1 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/24 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.
Vascular disorders Hypotension	0.00% 0/4 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/18 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/25 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	4.2% 1/24 • Number of events 1 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.
General disorders Non-cardiac chest pain	0.00% 0/4 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/18 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/25 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	4.2% 1/24 • Number of events 1 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.
Cardiac disorders Bradycardia	0.00% 0/4 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/18 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/25 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	4.2% 1/24 • Number of events 1 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/18 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	0.00% 0/25 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.	4.2% 1/24 • Number of events 1 • 28 days Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.

Other adverse events

Additional Information

Wendy Painter, MD, MPH

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