An International Observational Study of Outpatients with SARS-CoV-2 Infection

This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 who have been assessed as not requiring hospitalization (outpatients). Adults who seek testing for SARS-CoV-2 will be screened following consent. Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. The general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. Secondary outcomes include participant-reported health status and change in severity of shortness of breath, if participants develop this. As the understanding of the natural history of COVID-19 improves based on this and other studies, inclusion criteria and the data collection plan, including the outcomes assessed in this protocol, may be modified.