NCT04361552

Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Cerebrovascular Accident
• Chronic Obstructive Pulmonary Disease
• Chronic Renal Failure
• Coronary Artery Disease
• Diabetes Mellitus
• Malignant Neoplasm
• SARS Coronavirus 2 Infection

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
BIOLOGICAL	Tocilizumab	Given IV

Timeline

• Start date: 2020-04-07
• Primary completion: 2020-06-02
• Completion: 2020-06-02
• First posted: 2020-04-24
• Last updated: 2020-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study