Tocilizumab for the Prevention of Respiratory Failure and Death in Patients with Severe COVID-19 Infection
- Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study
- COVID-19 polymerase chain reaction (PCR) positive on nasopharyngeal swab
- 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 non-intubated patients (pts)
- Fever of 38.5 Celsius (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 uncontrolled malignant disease, with a life expectancy of 3 months or less
I. To evaluate the impact of tocilizumab administration on progression of respiratory failure in patients infected with severe COVID-19.
I. Overall survival.
II. Protocol-defined therapeutic response to tocilizumab.
III. Mechanical ventilation-free days (for both cohorts) at 4 weeks.
IV. To assess the safety of tocilizumab in patients with severe COVID-19 infection.
V. To assess treatment impact on CRP, IL-6 and cytokine levels, ferritin, lymphocyte phenotypes, coagulation parameters, immunoglobulin levels and antibody levels.
VI. To assess the impact on supplemental oxygen requirement, chest imaging and fever.
VII. To assess Sequential Organ Failure Assessment (SOFA) scores following tocilizumab administration in patients with severe COVID19 admitted to intensive care unit (ICU) who are intubated, on mechanical ventilation. (cohort 2)
VIII. To assess ability to produce antibody against SARS-CoV-2.
Patients receive tocilizumab intravenously (IV) on day 1. Patients whose condition is not improving and do not experience side effects to study drug, may receive a second dose between 1-5 days after first dose.
Trial Phase Phase II
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
- Primary ID 20-185
- Secondary IDs NCI-2020-03437
- Clinicaltrials.gov ID NCT04377659