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Tocilizumab for the Prevention of Respiratory Failure and Death in Patients with Severe COVID-19 Infection

Trial Status: Closed to Accrual

This phase II trial studies the effect of tocilizumab in preventing respiratory failure and death in patients with severe COVID-19 infection. Part of the complications from the COVID-19 infection may be due to the virus causing damage to the lungs, some of this damage may be caused by an extreme inflammatory reaction produced by the immune system as it tries to fight off the virus. A protein called IL-6 (interleukin 6) plays a major role in this type of inflammation. Tocilizumab may prevent IL-6 from attaching to cells. By blocking IL-6, tocilizumab may prevent damage to the lungs and reduce the need for treatment with a mechanical ventilator. If a patient is already receiving mechanical ventilation to assist with breathing, tocilizumab may improve the patient’s condition enough to allow this treatment to be stopped.

Inclusion Criteria

  • 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

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 uncontrolled malignant disease, with a life expectancy of 3 months or less

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Boglarka Gyurkocza
Phone: 646-608-3768

PRIMARY OBJECTIVE:

I. To evaluate the impact of tocilizumab administration on progression of respiratory failure in patients infected with severe COVID-19.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Boglarka Gyurkocza

  • Primary ID 20-185
  • Secondary IDs NCI-2020-03437
  • Clinicaltrials.gov ID NCT04377659