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Sarilumab COVID-19

Sarilumab COVID-19

Last Updated: 2025-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-28

Study Completion Date

2020-09-02

Brief Summary

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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.

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Detailed Description

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An individual participant would complete the study approximately 60 days from screening to follow-up on day 60 ±7 days.

Conditions

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Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sarilumab 200 mg

Sarilumab 200 milligrams (mg), single dose of intravenous (IV) injection on Day 1. Participants could receive a second dose of sarilumab 200 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 \[dated 08-Apr-2020\]):

* Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and
* Increase/recurrence of fever or
* Increase/no change in fraction of inspired oxygen (FiO2) requirement or
* Required vasopressors, extracorporeal membrane oxygenation (ECMO) or development of multi-organ dysfunction.

Group Type EXPERIMENTAL