Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
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.
Checked against the public recordLast updated Jun 18, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Emory University
- Interventions being studied
- Other: Best Practice; Biological: Tocilizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 18, 2020. Always confirm current availability with the study team.