Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

Study Overview

Phase 2:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata.

Phase 3 Cohort 1:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 on mechanical ventilation at baseline.

Phase 3 Cohort 2:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.

Phase 3 Cohort 3:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving high-intensity oxygen therapy* without mechanical ventilation at baseline.

  • High intensity oxygen therapy is defined as the use of non-rebreather mask with an oxygen flow rate of at least 10 L/min; use of a high flow device with at least 50% FiO2, or use of non-invasive ventilation (eg, BiPAP(TM)) or continuous positive airway pressure (CPAP) to treat hypoxemia.

Study Description

An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients with COVID-19

  • ClinicalTrials.gov Identifier: NCT04315298
  • Protocol Number: 2020C000259
  • Principal Investigator: Robert Hallowell

Recruitment Status

Open

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