The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)

Inclusion Criteria

• Has COVID-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days):
• Fevers OR
• At least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia OR
• Anosmia OR
• other clinical symptoms or signs of COVID-19 that are not otherwise explained by comorbidities or co-diagnoses
• PCR+ test for SARS-CoV-2.
• Has new signs or symptoms of COVID-19 that began ≤7 days of anticipated first dose of study drug.
• Persons ≥18 years old.
• at the time of first dose.
• ≥18 years old.
• Is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (SOC).
• Is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study drug.

Pregnancy and Contraception: In nonclinical developmental and reproductive toxicity studies, developmental toxicity including malformation was observed in fetuses from pregnant animals dosed with EIDD-2801 (MK 4482). Therefore, treatment with EIDD-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during the study and for 4 days after completion of EIDD 2801 dosing in female participants and for 4 days after completion of EIDD-2801 dosing in female partners of male participants.

• A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) OR
• Is 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 be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 2 during the intervention period and for at least 4 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention.
• Additional requirements for pregnancy testing during and after study intervention are located in Section 4.4.
• The investigator is 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 should 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 must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to Appendix 2.
• Male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
• Must agree to use contraception unless confirmed to be azoospermic (va