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

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.

Detailed Description

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

Completed
COVID-19

Drug: Sarilumab

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

Drug: Placebo

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

Eligibility Criteria

Key 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

Key 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

NOTE: Other protocol defined inclusion / exclusion criteria may apply

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Regeneron Study Site
Los Angeles, California, United States

Regeneron Study Site
Sacramento, California, United States

Regeneron Study Site
Santa Monica, California, United States

Regeneron Study Site
Aurora, Colorado, United States

Regeneron Study Site
Denver, Colorado, United States

Regeneron Study Site
New Haven, Connecticut, United States

Regeneron Study Site
Washington, District of Columbia, United States

Regeneron Study Site
Gainesville, Florida, United States

Regeneron Study Site
Orlando, Florida, United States

Regeneron Study Site
Tampa, Florida, United States

Regeneron Study Site
Atlanta, Georgia, United States

Regeneron Study Site
Decatur, Georgia, United States

Regeneron Study Site
Marietta, Georgia, United States

Regeneron Study Site
Chicago, Illinois, United States

Regeneron Study Site
Chicago, Illinois, United States

Regeneron Study Site
New Orleans, Louisiana, United States

Regeneron Study Site
Boston, Massachusetts, United States

Regeneron Study Site
Boston, Massachusetts, United States

Regeneron Study Site
Boston, Massachusetts, United States

Regeneron Study Site
Ann Arbor, Michigan, United States

Regeneron Study Site
Rochester, Minnesota, United States

Regeneron Study Site
Edison, New Jersey, United States

Regeneron Study Site
Hackensack, New Jersey, United States

Regeneron Study Site
Livingston, New Jersey, United States

Regeneron Study Site
Morristown, New Jersey, United States

Regeneron Study Site
Neptune, New Jersey, United States

Regeneron Study Site
Newark, New Jersey, United States

Regeneron Study Site
Teaneck, New Jersey, United States

Regeneron Study Site
Bronx, New York, United States

Regeneron Study Site 1
Bronx, New York, United States

Regeneron Study Site 2
Bronx, New York, United States

Regeneron Study Site
Bronx, New York, United States

Regeneron Study Site
Brooklyn, New York, United States

Regeneron Study Site
Buffalo, New York, United States

Regeneron Study Site
Elmhurst, New York, United States

Regeneron Study Site 1
Manhasset, New York, United States

Regeneron Study Site 2
Manhasset, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site 1
New York, New York, United States

Regeneron Study Site 2
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
Stony Brook, New York, United States

Regeneron Study Site
Valhalla, New York, United States

Regeneron Study Site
Tulsa, Oklahoma, United States

Regeneron Study Site
Portland, Oregon, United States

Regeneron Study Site
Portland, Oregon, United States

Regeneron Study Site
Danville, Pennsylvania, United States

Regeneron Study Site
Philadelphia, Pennsylvania, United States

Regeneron Study Site
Scranton, Pennsylvania, United States

Regeneron Study Site
Wilkes-Barre, Pennsylvania, United States

Regeneron Study Site
Dallas, Texas, United States

Regeneron Study Site
Dallas, Texas, United States

Regeneron Study Site
Murray, Utah, United States

Regeneron Study Site
Falls Church, Virginia, United States

Regeneron Study Site
Richmond, Virginia, United States

Regeneron Study Site
Everett, Washington, United States

Regeneron Study Site
Renton, Washington, United States

Clinical Trial Management, Study Director
Regeneron Pharmaceuticals

NCT Number
Keywords
Covid-19
SARS-CoV-2
Coronavirus
IL-6
sarilumab
Acute Respiratory Distress Syndrome
treatment
MeSH Terms
COVID-19