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Evaluation of the Efficacy an...

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

Last Updated: 2021-09-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-18

Study Completion Date

2020-09-02

Brief Summary

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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.

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Detailed Description

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

Conditions

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COVID-19

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 200mg IV (P2)

Phase 2

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Placebo

Intervention Type DRUG

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Sarilumab 200mg IV (P3:C1)

Phase 3: Cohort 1

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Placebo

Intervention Type DRUG

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Sarilumab 400mg IV (P2)

Phase 2

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Placebo

Intervention Type DRUG

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Sarilumab 400mg IV (P3:C1)

Phase 3: Cohort 1

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Placebo

Intervention Type DRUG

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Sarilumab 800mg IV (P3:C2)

Phase 3: Cohort 2

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Placebo

Intervention Type DRUG

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Sarilumab 800mg IV (P3: C3)

Phase 3: Cohort 3

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Placebo

Intervention Type DRUG

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Interventions

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Sarilumab

Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.

Intervention Type DRUG

Placebo

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Intervention Type DRUG

Other Intervention Names

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Kevzara® REGN88 SAR153191

Eligibility Criteria

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Inclusion Criteria

* Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), result from any specimen (or other commercial or public health assay) within 2 weeks prior to randomization and no alternative explanation for current clinical condition
* Hospitalized with illness of any duration with evidence of pneumonia, requires supplemental oxygen and/or assisted ventilation and meets one of the following:
* Phase 2 and Phase 3 Cohort 1:

Meets 1 of the following criteria at baseline:

* Severe disease OR
* Critical disease OR
* Multi-system organ dysfunction OR
* Immunocompromised
* Phase 3 Cohort 2:

Patients must be receiving mechanical ventilation to treat respiratory failure due to COVID-19

* Phase 3 Cohort 3:

Patients must be receiving supplemental oxygen to treat hypoxemia delivered by one of the following devices:

* Non-rebreather mask, OR
* High-flow device with at least 50% FiO2, OR
* Non-invasive positive pressure ventilator
* Ability to provide informed consent signed by study patient or legally acceptable representative
* Willingness and ability to comply with study-related procedures/assessments

Exclusion Criteria

* In the opinion of the investigator, not expected to survive for more than 48 hours from screening
* Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN), platelets \<50,000 per mm3
* Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period
* Current treatment with the simultaneous combination of leflunomide and methotrexate
* Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections
* Participation in a double-blind clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit (The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID-19 treatments in the context of an open-label study, Emergency Use Authorization (EUA), compassionate use protocol or open-label use is permitted)
* Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
* Known systemic hypersensitivity to sarilumab or the excipients of the drug product
* Phase 3 Cohort 2 and Cohort 3 only:
* Known or suspected history of immunosuppression or immunodeficiency disorder
* Patients who require renal replacement therapy for acute kidney injury at randomization or who required renal replacement therapy within 72 hours prior to randomization
* Patients who have circulatory shock requiring vasopressors at randomization or within 24 hours prior to randomization
* Use of extracorporeal life support (eg, ECMO) or, in the opinion of the investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Los Angeles, California, United States

Site Status

Regeneron Study Site

Sacramento, California, United States

Site Status

Regeneron Study Site

Santa Monica, California, United States

Site Status

Regeneron Study Site

Aurora, Colorado, United States

Site Status

Regeneron Study Site

Denver, Colorado, United States

Site Status

Regeneron Study Site

New Haven, Connecticut, United States

Site Status

Regeneron Study Site

Washington D.C., District of Columbia, United States

Site Status

Regeneron Study Site

Gainesville, Florida, United States

Site Status

Regeneron Study Site

Orlando, Florida, United States

Site Status

Regeneron Study Site

Tampa, Florida, United States

Site Status

Regeneron Study Site

Atlanta, Georgia, United States

Site Status

Regeneron Study Site

Decatur, Georgia, United States

Site Status

Regeneron Study Site

Marietta, Georgia, United States

Site Status

Regeneron Study Site

Chicago, Illinois, United States

Site Status

Regeneron Study Site

Chicago, Illinois, United States

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Regeneron Study Site

New Orleans, Louisiana, United States

Site Status

Regeneron Study Site

Boston, Massachusetts, United States

Site Status

Regeneron Study Site

Boston, Massachusetts, United States

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Regeneron Study Site

Boston, Massachusetts, United States

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Regeneron Study Site

Ann Arbor, Michigan, United States

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Regeneron Study Site

Rochester, Minnesota, United States

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Regeneron Study Site

Edison, New Jersey, United States

Site Status

Regeneron Study Site

Hackensack, New Jersey, United States

Site Status

Regeneron Study Site

Livingston, New Jersey, United States

Site Status

Regeneron Study Site

Morristown, New Jersey, United States

Site Status

Regeneron Study Site

Neptune City, New Jersey, United States

Site Status

Regeneron Study Site

Newark, New Jersey, United States

Site Status

Regeneron Study Site

Teaneck, New Jersey, United States

Site Status

Regeneron Study Site

Brooklyn, New York, United States

Site Status

Regeneron Study Site

Buffalo, New York, United States

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Regeneron Study Site

Elmhurst, New York, United States

Site Status

Regeneron Study Site 1

Manhasset, New York, United States

Site Status