PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19

This multicenter trial will be conducted in both domestic and international sites. The study will compare IPs to control in standard and intermediate risk, non-hospitalized adult SARS-CoV-2 infected participants and uninfected adult contacts of SARS-CoV-2 confirmed cases. The master protocol will outline the core elements of the study. Investigational products may be included in either or both study indications: early treatment and post-exposure prophylaxis (PEP). The study includes a phase 2 evaluation for all IPs. The platform trial design will allow for multiple IPs to be incorporated into the protocol as product specific appendices (PSA) as products are identified and become available. Each PSA will detail the interventions, the endpoints, target treatment effect, intended statistical analysis, the relevant control arms, and the sample size range. The PSA may define additional adaptive design elements, such as early declaration rules.