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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Criteria

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