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An adaptive phase 2/3, randomized, double-blind, placebo-controlled study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19
COVID-19 Research Area(s): Vaccines & Treatments
This study is an adaptive, multi-national, multi-center, Phase 2/3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of sarilumab in hospitalized adults with severe or critical COVID19. Patients will be randomized in a 2:2:1 ratio to sarilumab 400 mg intravenous (IV), 200 mg IV, or matching placebo IV in a stratified manner. Randomization will be stratified by severity of illness (severe, critical, multisystem organ dysfunction) and use of systemic corticosteroids (Yes, No). Screening will be limited to severe patients until approximately 100 patients have reached Day 15, after which screening can be considered for patients of the same or greater severity.