Status:
WITHDRAWN
Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cerebrovascular Accident
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 inten...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04361552
Start Date
April 7 2020
End Date
June 2 2020
Last Update
June 18 2020
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322