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

  • STATUS
    Not Recruiting
  • days left to enroll
    27
  • participants needed
    2500
  • sponsor
    Regeneron Pharmaceuticals
Updated on 25 January 2021
Investigator
Clinical Trials Administrator
Primary Contact
Regeneron Study Site (6.8 mi away) Contact
+51 other location
pneumonia
mechanical ventilation
respiratory failure
covid-19
SARS
PCR test

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 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) or continuous positive airway pressure (CPAP) to treat hypoxemia.

Details
Condition *COVID-19, Covid-19, COVID-19
Treatment Placebo, Sarilumab
Clinical Study IdentifierNCT04315298
SponsorRegeneron Pharmaceuticals
Last Modified on25 January 2021

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