At a glance
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Randomized Master Protocol for Immune Modulators for Treating COVID-19
In Brief
A Phase 3 clinical trial evaluating Infliximab, Abatacept, and 2 other interventions for Covid19. Completed, enrolled 1,971 participants across 91 sites in 5 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
study drug or matching placebo
study drug or matching placebo
Standard of Care
study drug or matching placebo