Randomized Master Protocol for Immune Modulators for Treating COVID-19

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the
treatment of moderately or severely ill patients infected with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with
respect to speed of recovery, mortality, illness severity, and hospital resource utilization.
Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the
local clinics, including remdesivir (provided). The SoC may change during the course of the
study based on other research findings. Comparisons of the agents among themselves is not a
research objective.

The study population corresponds to moderately and severely ill patients infected with the
coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already
hospitalized for treatment of COVID-19 infection as well as patients being treated for
COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital.
Patients both in and out of the ICU are included in the study population.