NCT04315298

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,912 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 receiving 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.

Detailed description

Phase 2 and Phase 3 Cohort 1 completed. Cohorts 2 and 3 terminated early based on Phase 3 Cohort 1 results.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Sarilumab	Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.
DRUG	Placebo	Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Timeline

• Start date: 2020-03-18
• Primary completion: 2020-07-24
• Completion: 2020-09-02
• First posted: 2020-03-19
• Last updated: 2021-09-23
• Results posted: 2021-09-23

Locations

62 sites across 1 country: United States

Regulatory

• FDA-regulated drug study