Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
Withdrawn before enrolling · Phase 3
Conditions studied: Cerebrovascular Accident, Chronic Obstructive Pulmonary Disease, Chronic Renal Failure, Coronary Artery Disease, Diabetes Mellitus, Malignant Neoplasm, SARS Coronavirus 2 Infection
In brief
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.
Key facts
- Study ID
- NCT04361552
- Run by
- Emory University
- People needed
- 0
- Starts
- 2020-04-07
- Expected to finish
- 2020-06-02
- Last updated by the study team
- 2020-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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