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Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients with SARS-CoV-2 Infection

Trial Status: Administratively Complete

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substances (cytokines) made by cells of the immune system as a response to SARS-CoV-2 infection. Tocilizumab may help lower the body’s immune response and reduce inflammation. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

Inclusion Criteria

  • Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved)
  • Should be hospitalized and exhibit at least one of the following predictors of mortality * Age >= 65 years * Current smoker (smoked >= 100 cigarettes in life and actively smoking) * Chronic obstructive pulmonary disease (COPD) * Diabetes * Hypertension * Coronary artery disease * Cerebrovascular accident (CVA) * Chronic renal disease (creatinine of >= 2 mg/dl) * Cancer * Patients that have C-reactive protein (CRP) >= 10 mg/L * D-dimer >= 0.5 mg/L * Procalcitonin >= 0.5 mg/L * Lactate dehydrogenase (LDH) >= upper limit of normal (ULN)
  • Patients or authorized family member willing to sign informed consent to participate in this study

Exclusion Criteria

  • Pregnant or lactating women
  • Hypersensitivity to tocilizumab
  • Patients or authorized family member unwilling to sign informed consent to participate in this study
  • Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
Contact: Ajay Kumar Nooka
Phone: 404-778-1900

PRIMARY OBJECTIVE:

I. To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2.

SECONDARY OBJECTIVES:

I. To decrease the rates of intensive care unit (ICU) transfer.

II. To decrease the rate of invasive mechanical ventilation (MV).

III. To decrease the length of ICU stay.

IV. To decrease the rate of tracheostomy.

V. Safety and efficacy of tocilizumab.

VI. Biomarker assessment for response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive tocilizumab intravenously (IV) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.

ARM II: Patients receive standard of care.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Ajay Kumar Nooka

  • Primary ID WINSHIP4998-20
  • Secondary IDs NCI-2020-02314
  • Clinicaltrials.gov ID NCT04361552