NCT04362111

Early Treatment of Cytokine Storm Syndrome in Covid-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.

Detailed description

The first aim of this project is to determine whether rapidly assayed early clinical laboratory markers of CSS (eCSS: leucopenia, lymphopenia, and elevated ferritin, d-dimer, LDH, CRP, and AST/ALT) in patients admitted to the hospital with respiratory compromise in the setting of Covid-19 infection can accurately identify patients with CSS as defined by validated CSS case definitions (H-Score, aHLH-2004). Confirmation of eCSS predictive of evolving CSS will identify patients at risk for rapid deterioration of lung function and inform early initiation of treatment for CSS. Genotyping studies will also be performed on patients with confirmed CSS to determine whether perforin pathway mutations commonly present in CSS associated with other disorders are present. The second aim is to determine whether early treatment with rhIL-1Ra (anakinra) in patients admitted to the hospital with markers of CSS improves or prevents deterioration of respiratory dysfunction and prevents the development of respiratory failure requiring mechanical ventilation.

Conditions

• Cytokine Storm
• COVID-19

Interventions

Type	Name	Description
DRUG	Anakinra	The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days
DRUG	Normal saline	The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-31
• Completion: 2023-06-01
• First posted: 2020-04-24
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study