Testing the Safety and Effectiveness of Experimental Sarilumab in Hospitalized Patients With COVID-19 (Coronavirus)
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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: COVID-19, coronavirus, viral infection, COVID-19 infection, coronavirus infection, hospitalization, coronavirus hospitalization
Type: Drug study, Phase 2/3
Target:
20 Participants
Investigator:
Description
You are being asked to take part in a research study because you have the COVID‑19 virus. This study will test the safety and effectiveness of the experimental drug, sarilumab (study drug). This study is sponsored by Regeneron Pharmaceuticals, Inc. (“Regeneron”).

Sarilumab (also known as Kevzara®) is considered an experimental drug in this study. It has not been approved by the FDA for the condition being studied. However, it has been approved in multiple countries for active rheumatoid arthritis.

Sarilumab is a type of drug called a “monoclonal antibody”. An antibody is a special kind of protein that your immune (defense) system normally makes to fight bacteria and viruses. Scientists can now make antibodies in the laboratory for the treatment of many different diseases. Sarilumab has been specifically shown to block the action of a protein called interleukin-6 (IL-6) in your body. Interleukin-6 (IL-6) is a protein in the immune system that has been shown to play an important role in inflammation. Inflammation may be associated with symptoms and complications of COVID‑19.

The main purpose of this study is to determine if sarilumab is safe and if it can decrease the amount of time you have COVID-19 symptoms.
This study requires

This is a randomized, double-blind, placebo-controlled study. “Randomized” means that the group you will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. “Double-blind” means that neither you nor the study doctor will know which treatment group you have been placed in (ie, if you are receiving sarilumab or placebo). This is done to make sure the results of the study cannot be influenced by anyone. If there is an urgent need, the study doctor can find out quickly if you are receiving sarilumab or placebo. A placebo is an inactive substance, that looks like the medicine, but which contains no medicine. If you agree to take part in this study, you will receive either the sarilumab or placebo. You will have a 4 out of 5 or 80% chance of receiving the sarilumab.

This study consists of:

  • A screening visit (1 day)
  • A baseline visit (1 day) which can occur at the same time as the screening visit, if necessary.
  • Monitoring period (58 to 59 days) or until discharged
  • Follow-up telephone call at day 60, or earlier if you are discharged before the end of the study

You will be randomly assigned to 1 of 3 possible study treatments. The study drug or placebo will be given through a vein (intravenous [IV] infusion).

You will be given either:

  • 200 mg of sarilumab, IV, single dose
  • 400 mg of sarilumab, IV, single dose
  • Placebo, IV, single dose

Sarilumab has been approved for subcutaneous (under the skin) use. This is the first study where 200 mg and 400 mg IV infusion will be given to human volunteers and the first study in which the 400 mg dose will be used.

Who can participate

Inclusion criteria:

  • Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay
  • Hospitalized with illness of any duration with evidence of pneumonia and severe disease, critical disease, or multi-system organ dysfunction at baseline
  • 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, unlikely to survive for >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) greater than 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 conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents
  • Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day
  • History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis
  • Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections
  • 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 any 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 remdisivir in the context of a single-arm remdisivir compassionate use protocol is permitted)
  • Any physical examination findings and/or history of any illness 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 NOTE: Other protocol defined inclusion / exclusion criteria may apply
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
Your participation in this study may last up to 60 days or until you are discharged from the hospital.
Recruitment period
From March 20, 2020
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • COVID-19

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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