Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection

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

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.

Inclusion Criteria:

• Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study.
• COVID-19 PCR positive on nasopharyngeal swab
• Aged >/= 18 years old
• Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate >/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) < 93% on room air for nonintubated pts.
• Fever of 38.5 C or suspected respiratory infection
• IL-6 level >/= 80 pcg/ml
• Cohort #1 - non intubated Cohort #2 - intubated
• Women of childbearing potential must have a negative serum or urine pregnancy test
• Patients receiving ongoing steroid therapy are eligible
• Patients will be allowed to receive concurrent or sequential treatment with remdesivir

Exclusion Criteria:

• Patients with uncontrolled systemic fungal and bacterial infections
• Patients with latent tuberculosis
• Patients with known hypersensitivity to tocilizumab or any component of the formulation
• Concurrent initiation of steroid therapy is not allowed
• Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less