NCT05665153

Symphony IL-6 Study in Patients at Risk of Severe Sepsis

Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Bluejay Diagnostics, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment in a near patient setting. This study is to establish an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 and/or influenza infection.

Conditions

• Severe Sepsis

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-08-21
• Completion: 2024-11-21
• First posted: 2022-12-27
• Last updated: 2023-09-07

Locations

1 site across 1 country: United States