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

Inclusion Criteria

• Able to provide informed consent prior to initiation of any study procedures.
• ≥18 years of age at Screening.
• Study treatment is expected to begin within ≤168 hours from first symptom onset.
• Ability to swallow pills.
• Documentation of confirmed active SARS-CoV-2 infection, as determined by a molecular or non-molecular ("rapid") test conducted at any clinic or laboratory that had a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from a sample collected ≤96 hours prior to study entry.
• Was experiencing at least one of the following SARS-CoV-2 infection symptoms at the time of enrollment: fever (could be subjective including feeling feverish or having chills) OR signs/symptoms of respiratory illness (including but not limited to upper respiratory congestion, loss of sense of smell or taste, sore throat OR lower respiratory illness - cough, shortness of breath).
• Agreed to not participate in another interventional clinical trial for the treatment of SARS-CoV-2 during the study period (28 days) unless hospitalized.
• Agreed to not obtain investigational medications outside of the molnupiravir study.
• Agreed to the sampling detailed in the schedule of evaluations and to comply with study requirements including contraception requirements.
• A female participant was eligible to participate if she was not pregnant or breastfeeding and at least one of the following conditions applied:
• Was not a woman of childbearing potential (WOCBP) OR
• Was a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user-dependent method in combination with a barrier method), or was abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 2 of the study protocol during the intervention period and for at least 50 days after the last dose of study intervention. The investigator evaluated the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
• A WOCBP must have had a negative highly sensitive pregnancy test (serum or urine) within 24 hours before the first dose of study intervention.
• Additional requirements for pregnancy testing during and after study intervention were provided in the study protocol.
• The investigator was responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• Contraceptive use by women was to be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19 (Benson et al, 2020; Spratt et al, 2020), estrogen-containing contraceptives could not be started to fulfill the contraceptive requirement of this study at any time during participant's participation. If contraceptives were interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence was practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use had to adhere to the guidance in Appendix 2 of the study protocol.
• Male participants were eligible to participate if they agreed to the following during the intervention period and for at least 100 days after the last dose of study intervention:
• Refrained from donating sperm

PLUS either:

• Were abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agreed to remain abstinent.

OR

• Had to agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause [Appendix 2 of the study protocol]) as detai