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.
Additional locations may be listed on ClinicalTrials.gov for NCT04361552.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorAjay Kumar Nooka
