CD2H COVID-19

Tocilizumab for Prevention of Respiratory Failure 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.

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

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

Arm	Description	Assigned Intervention
Experimental Intubation/Mechanical Ventilation	Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation	Drug: Tocilizumab Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
Experimental Respiratory Support	In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)	Drug: Tocilizumab Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.