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 substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. 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.
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 tociluzumab. 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.
Other: Best Practice
Receive standard of care
Other Name: Array
Biological: Tocilizumab
Given IV
Other Name: Array
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)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Ajay K Nooka, Principal Investigator
Emory University Hospital/Winship Cancer Institute