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Completed Phase 2Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04315298

Public ClinicalTrials.gov record NCT04315298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04315298
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
1,912 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 18, 2020 (Actual)
Primary completion
Jul 24, 2020 (Actual)
Completion
Sep 2, 2020 (Actual)
Last update posted
Sep 23, 2021

2020

United States locations

U.S. sites
62
U.S. states
20
U.S. cities
45
Facility City State ZIP Site status
Regeneron Study Site Los Angeles California 90095 —
Regeneron Study Site Sacramento California 95817 —
Regeneron Study Site Santa Monica California 90404 —
Regeneron Study Site Aurora Colorado 80045 —
Regeneron Study Site Denver Colorado 80206 —
Regeneron Study Site New Haven Connecticut 06520 —
Regeneron Study Site Washington D.C. District of Columbia 20010 —
Regeneron Study Site Gainesville Florida 32610 —
Regeneron Study Site Orlando Florida 32803 —
Regeneron Study Site Tampa Florida 33606 —
Regeneron Study Site Atlanta Georgia 30322 —
Regeneron Study Site Decatur Georgia 30033 —
Regeneron Study Site Marietta Georgia 30060 —
Regeneron Study Site Chicago Illinois 60611 —
Regeneron Study Site Chicago Illinois 60612 —
Regeneron Study Site New Orleans Louisiana 70112 —
Regeneron Study Site Boston Massachusetts 02111 —
Regeneron Study Site Boston Massachusetts 02114 —
Regeneron Study Site Boston Massachusetts 02215 —
Regeneron Study Site Ann Arbor Michigan 48109 —
Regeneron Study Site Rochester Minnesota 55905 —
Regeneron Study Site Edison New Jersey 08820 —
Regeneron Study Site Hackensack New Jersey 07601 —
Regeneron Study Site Livingston New Jersey 07039 —
Regeneron Study Site Morristown New Jersey 07960 —
Regeneron Study Site Neptune City New Jersey 07753 —
Regeneron Study Site Newark New Jersey 07112 —
Regeneron Study Site Teaneck New Jersey 07666 —
Regeneron Study Site Brooklyn New York 11219 —
Regeneron Study Site Buffalo New York 14263 —
Regeneron Study Site Elmhurst New York 11373 —
Regeneron Study Site 1 Manhasset New York 11030 —
Regeneron Study Site 2 Manhasset New York 11030 —
Regeneron Study Site New York New York 10003 —
Regeneron Study Site New York New York 10016 —
Regeneron Study Site 1 New York New York 10025 —
Regeneron Study Site 2 New York New York 10025 —
Regeneron Study Site New York New York 10029 —
Regeneron Study Site New York New York 10032 —
Regeneron Study Site New York New York 10037 —
Regeneron Study Site New York New York 10065 —
Regeneron Study Site New York New York 10075 —
Regeneron Study Site Stony Brook New York 11794 —
Regeneron Study Site The Bronx New York 10451 —
Regeneron Study Site 1 The Bronx New York 10461 —
Regeneron Study Site 2 The Bronx New York 10461 —
Regeneron Study Site The Bronx New York 10467 —
Regeneron Study Site Valhalla New York 10595 —
Regeneron Study Site Tulsa Oklahoma 74104 —
Regeneron Study Site Portland Oregon 97213 —
Regeneron Study Site Portland Oregon 97239 —
Regeneron Study Site Danville Pennsylvania 17822 —
Regeneron Study Site Philadelphia Pennsylvania 19140 —
Regeneron Study Site Scranton Pennsylvania 18510 —
Regeneron Study Site Wilkes-Barre Pennsylvania 18711 —
Regeneron Study Site Dallas Texas 75246 —
Regeneron Study Site Dallas Texas 75390 —
Regeneron Study Site Murray Utah 84107 —
Regeneron Study Site Falls Church Virginia 22042 —
Regeneron Study Site Richmond Virginia 23298 —
Regeneron Study Site Everett Washington 98201 —
Regeneron Study Site Renton Washington 98055 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04315298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 23, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04315298 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →