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Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405570
Recruitment Status : Completed
First Posted : May 28, 2020
Results First Posted : February 16, 2022
Last Update Posted : February 16, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Ridgeback Biotherapeutics, LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition SARS-CoV-2 Infection, COVID-19
Interventions Drug: Molnupiravir 200 mg
Drug: Molnupiravir 400 mg
Drug: Molnupiravir 800 mg
Drug: Placebo (PBO)
Enrollment 204
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Hide Arm/Group Description molnupiravir twice daily (BID) for 5 days molnupiravir twice daily (BID) for 5 days molnupiravir twice daily (BID) for 5 days Placebo twice daily (BID) for 5 days
Period Title: Overall Study
Started 23 64 55 62
Number of Subjects Randomized Not Dosed 0 2 0 0
Number of Subjects in the Safety Population 23 62 55 62
Number of Subjects in the mITT Population 23 61 53 61
Completed 23 59 52 61
Not Completed 0 5 3 1
Reason Not Completed
Adverse Event             0             1             1             1
Lost to Follow-up             0             1             0             0
Physician Decision             0             0             1             0
Withdrawal by Subject             0             1             1             0
Randomized not dosed             0             2             0             0
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo Total
Hide Arm/Group Description molnupiravir twice daily (BID) for 5 days molnupiravir twice daily (BID) for 5 days molnupiravir twice daily (BID) for 5 days Placebo twice daily (BID) for 5 days Total of all reporting groups
Overall Number of Baseline Participants 23 62 55 62 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 62 participants 55 participants 62 participants 202 participants
36.5  (15.34) 42.4  (14.88) 42.2  (14.36) 39.7  (14.10) 40.8  (14.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 62 participants 55 participants 62 participants 202 participants
Female
11
  47.8%
32
  51.6%
27
  49.1%
34
  54.8%
104
  51.5%
Male
12
  52.2%
30
  48.4%
28
  50.9%
28
  45.2%
98
  48.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 62 participants 55 participants 62 participants 202 participants
Hispanic or Latino
7
  30.4%
23
  37.1%
33
  60.0%
23
  37.1%
86
  42.6%
Not Hispanic or Latino
16
  69.6%
39
  62.9%
21
  38.2%
39
  62.9%
115
  56.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 23 participants 62 participants 55 participants 62 participants 202 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.3%
2
   3.2%
1
   1.8%
2
   3.2%
6
   3.0%
Black or African American
3
  13.0%
3
   4.8%
3
   5.5%
2
   3.2%
11
   5.4%
White
17
  73.9%
56
  90.3%
49
  89.1%
54
  87.1%
176
  87.1%
Other
2
   8.7%
0
   0.0%
2
   3.6%
1
   1.6%
5
   2.5%
Multiple
0
   0.0%
1
   1.6%
0
   0.0%
3
   4.8%
4
   2.0%
1.Primary Outcome
Title Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
Hide Description

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
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT - modified Intent to Treat Population
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Hide Arm/Group Description:
molnupiravir twice daily (BID) for 5 days
molnupiravir twice daily (BID) for 5 days
molnupiravir twice daily (BID) for 5 days
Placebo twice daily (BID) for 5 days
Overall Number of Participants Analyzed 23 61 53 61
Measure Type: Count of Participants
Unit of Measure: Participants
Number (%) with response
21
  91.3%
48
  78.7%
49
  92.5%
49
  80.3%
Number (%) censored
2
   8.7%
13
  21.3%
4
   7.5%
12
  19.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Molnupiravir 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5551
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Molnupiravir 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7270
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Molnupiravir 800 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0128
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs
Hide Description

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
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT - modified Intent to Treat Population
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Hide Arm/Group Description:
molnupiravir twice daily (BID) for 5 days
molnupiravir twice daily (BID) for 5 days
molnupiravir twice daily (BID) for 5 days
Placebo twice daily (BID) for 5 days
Overall Number of Participants Analyzed 23 61 53 61
Median (95% Confidence Interval)
Unit of Measure: Days
22.0
(15.0 to 28.0)
27.0
(15.0 to 28.0)
14.0
(13.0 to 14.0)
15.0
(15.0 to 27.0)
3.Primary Outcome
Title Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Hide Arm/Group Description:
molnupiravir twice daily (BID) for 5 days
molnupiravir twice daily (BID) for 5 days
molnupiravir twice daily (BID) for 5 days
Placebo twice daily (BID) for 5 days
Overall Number of Participants Analyzed 23 62 55 62
Measure Type: Count of Participants
Unit of Measure: Participants
AEs leading to early discontinuation of blinded treatment (active or placebo)
0
   0.0%
1
   1.6%
1
   1.8%
1
   1.6%
AEs leading to study drug-related discontinuation of treatment
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
new grade 3 or higher AEs (not already present at baseline)
1
   4.3%
2
   3.2%
4
   7.3%
5
   8.1%
study drug-related new grade 3 or higher AEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher
Hide Description Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Hide Arm/Group Description:
EIDD-2801 twice daily (BID) for 5 days
EIDD-2801 twice daily (BID) for 5 days
EIDD-2801 twice daily (BID) for 5 days
Placebo twice daily (BID) for 5 days
Overall Number of Participants Analyzed 23 62 55 62
Measure Type: Count of Participants
Unit of Measure: Participants
5
  21.7%
7
  11.3%
6
  10.9%
9
  14.5%
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Hide Arm/Group Description EIDD-2801 twice daily (BID) for 5 days EIDD-2801 twice daily (BID) for 5 days EIDD-2801 twice daily (BID) for 5 days Placebo twice daily (BID) for 5 days
All-Cause Mortality
Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/62 (0.00%)      0/55 (0.00%)      0/62 (0.00%)    
Hide Serious Adverse Events
Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      2/62 (3.23%)      1/55 (1.82%)      1/62 (1.61%)    
Investigations         
Oxygen saturation decreased †  0/23 (0.00%)  0 1/62 (1.61%)  1 0/55 (0.00%)  0 0/62 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident †  0/23 (0.00%)  0 1/62 (1.61%)  1 0/55 (0.00%)  0 0/62 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure †  0/23 (0.00%)  0 0/62 (0.00%)  0 1/55 (1.82%)  1 0/62 (0.00%)  0
Hypoxia †  0/23 (0.00%)  0 0/62 (0.00%)  0 0/55 (0.00%)  0 1/62 (1.61%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Molnupiravir 200 mg Molnupiravir 400 mg Molnupiravir 800 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/23 (17.39%)      2/62 (3.23%)      1/55 (1.82%)      4/62 (6.45%)    
Nervous system disorders         
Dizziness †  2/23 (8.70%)  2 1/62 (1.61%)  3 0/55 (0.00%)  0 0/62 (0.00%)  0
Psychiatric disorders         
Insomnia †  2/23 (8.70%)  2 1/62 (1.61%)  1 1/55 (1.82%)  1 4/62 (6.45%)  4
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI is requested to obtain written consent from the Sponsor before anything relating to the study can be published.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wendy Painter
Organization: Ridgeback Biotherapeutics
Phone: 786-687-2495
EMail: EIDD2801@ridgebackbio.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ridgeback Biotherapeutics, LP
ClinicalTrials.gov Identifier: NCT04405570    
Other Study ID Numbers: EIDD-2801-2003
First Submitted: May 26, 2020
First Posted: May 28, 2020
Results First Submitted: January 18, 2022
Results First Posted: February 16, 2022
Last Update Posted: February 16, 2022