A Phase II Study of Tocilizumab to Prevent Respiratory Failure in Patients with Severe COVID-19 Infection

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Full Title

A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients with Severe COVID-19 Infection (COVID)

Purpose

The purpose of this study is to see if the drug tocilizumab can prevent respiratory failure in patients with severe COVID-19 infection. Researchers think that although some of the complications of COVID-19 result from the virus damaging the lungs, some of this damage may be caused by an extreme inflammatory reaction produced by the immune system as it tries to fight off the virus. A protein called interleukin 6 (IL-6) plays a major role in this type of inflammation, and several studies have shown very high levels of IL-6 in people with COVID-19. Tocilizumab prevents IL-6 from attaching to cells and causing the resulting inflammation that could damage the lungs and other organs.

By blocking IL-6, tocilizumab may prevent damage to the lungs and reduce the need for treatment with a mechanical ventilator. If a patient is already receiving mechanical ventilation to assist with breathing, the study drug may improve the patient’s condition enough to allow this treatment to be stopped.

Tocilizumab is given intravenously (by vein). It is used to treat arthritis and an inflammatory syndrome that might be associated with a certain kind of immunotherapy; its use in this study is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients age 18 and older who are hospitalized for severe COVID-19 infection.
  • Patients need to have elevated levels of IL-6 (over 80 pg/ml).
  • Patients may not be receiving ongoing or concurrent treatment with remdesivir.

For more information about this study, please contact Dr. Boglarka Gyurkocza at 646-608-3768.

Protocol

20-185

Phase

II

Investigator