Table 1.

Patient, intervention, comparison, outcome, time, and study design (PICOTS) criteria for study inclusion

Study variable	Inclusion criteria	Exclusion criteria
Population	Confirmed SARS-CoV-2 infection diagnosis (by either nucleic acid amplification test or rapid antigen test) occurring after the approval date of molnupiravir in each country included within a study Outpatients Population-based samples (non-disease specific) Age ≥ 18 years	Populations with specific medical conditions other than SARS-CoV-2 infection diagnosis
Intervention	Prescription for molnupiravir
Comparison	People with confirmed SARS-CoV-2 infection diagnosis who did not receive any antiviral agent, including nirmatrelvir/ritonavir, remdesivir, or any monoclonal antibody	Studies comparing MOV only to other approved antiviral agents
Outcome	All-cause hospitalization All-cause death COVID-19-related hospitalization COVID-19-related death Related outcomes such as all-cause or COVID-19-related ICU admission or IMV use
Time	January 1, 2021–March 10, 2023
Study design	Non-interventional real-world studies Estimation of a relative risk measure with corresponding confidence interval Covariate adjustment Longitudinal data analysis	Clinical trials Single-arm studies

ICU intensive care unit, IMV invasive mechanical ventilation