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:
Ridgeback Biotherapeutics, LP
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Ridgeback Biotherapeutics, LP
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Molnupiravir 200 mg | Molnupiravir 400 mg | Molnupiravir 800 mg | Placebo |
---|---|---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Molnupiravir 200 mg | Molnupiravir 400 mg | Molnupiravir 800 mg | Placebo | Total | |
---|---|---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
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):
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 |