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Sarilumab COVID-19

NCT04327388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2025-09-24

Study results available
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Summary

Primary Objective:

To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19).

Secondary Objectives:

* Evaluate the 28-day survival rate.
* Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity.
* Evaluate changes in the National Early Warning Score 2.
* Evaluate the duration of predefined symptoms and signs (if applicable).
* Evaluate the duration of supplemental oxygen dependency (if applicable).
* Evaluate the incidence of new mechanical ventilation use during the study.
* Evaluate the duration of new mechanical ventilation use during the Study.
* Evaluate the proportion of participants requiring rescue medication during the 28-day period.
* Evaluate need for admission into intensive care unit.
* Evaluate duration of hospitalization (days).
* The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of:

* Serious adverse events.
* Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia.
* Grade greater than or equal to (\>=) 2 infusion related reactions.
* Grade \>=2 hypersensitivity reactions.
* Increase in alanine transaminase (ALT) \>=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline).
* Major or opportunistic bacterial or fungal infections.

Conditions

  • Corona Virus Infection

Interventions

DRUG

Sarilumab SAR153191

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-28
Primary Completion
2020-07-31
Completion
2020-09-02
FDA Drug
Yes

Countries

  • Argentina
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327388 on ClinicalTrials.gov