Design overview, setting, and participants
CANCER, DISEASE
Non-hospitalized adults ≥ 18 years old with laboratory-confirmed mild-to-moderate COVID-19 and at least one risk factor for progression to severe disease were included in the phase 3 component of MOVe-OUT (ClinicalTrials.gov NCT04575597). Participants were randomized within 5 days of onset of COVID-19 signs or symptoms and received molnupiravir 800 mg every 12 h or matching placebo for 5 days. Nasopharyngeal swabs and blood samples were collected at baseline on Day 1 and on Days 3, 5, 10, 15, and 29. MOVe-OUT was conducted in accordance with local and/or national regulations (including all applicable data protection laws and regulations), International Council for Harmonization-Good Clinical Practice, and the ethical principles that have their origin in the Declaration of Helsinki regarding independent ethics committee review, informed consent, and the protection of human participants in biomedical research. The full details of the phase 3 component of MOVe-OUT, along with the study protocol, are reported in Jayk Bernal, A. et al. [Immunocompromised participants were identified based on a post hoc review of medical history and/or prior and concomitant use of systemic corticosteroids or immunosuppressant medications, as classified in H02AB and L04 of the World Health Organization Anatomical Therapeutic Chemical Classification System code. The following criteria were applied to identify immunocompromised participants: prior use of systemic corticosteroids for ≤ 4 weeks prior to receipt of the first dose of study drug; prior and/or concomitant use of immunosuppressants for an underlying condition(s); and/or medical history of immunocompromising conditions, including HIV (PLWH receiving a stable antiretroviral regimen), hematopoietic stem cell or solid organ transplant recipient, and active cancer