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

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

Sponsored by Regeneron Pharmaceuticals


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 severity strata.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 400 participants Primary Purpose: Treatment Actual Study Start Date: March 18, 2020 Estimated Study Completion Date: April 1, 2021

Who is this study for?

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 and severe disease, critical disease, multi-system organ dysfunction or immunocompromised at baseline

Key Exclusion Criteria:

  • In the opinion of the investigator, not expected to survive for more than 48 hours from screening
  • 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
  • Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin or plans to receive during the study period
  • 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 or compassionate use protocol is permitted)

NOTE: Other protocol defined inclusion / exclusion criteria may apply

What should I expect?

Arm 1 (Sarilumab high dose) Drug: Sarilumab Single intravenous (IV) dose of sarilumab (Other Names:Kevzara®, REGN88, SAR153191)

Arm 2 (Sarilumab low dose) Drug: Sarilumab Single intravenous (IV) dose of sarilumab (Other Names:Kevzara®, REGN88, SAR153191)

Arm 3 (Placebo Comparator) Drug: Placebo Single intravenous (IV) dose of placebo to match sarilumab administration

Inpatient trial premium listing (no trial site names)

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.