The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
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.
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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Boglarka Gyurkocza, MD, Principal Investigator
Memorial Sloan Kettering Cancer Center