Symphony IL-6 Study in Patients at Risk of Severe Sepsis
Status unconfirmed
Conditions studied: Severe Sepsis
In brief
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.
Key facts
- Study ID
- NCT05665153
- Run by
- Bluejay Diagnostics, Inc.
- People needed
- 200
- Starts
- 2022-11-22
- Expected to finish
- 2024-11-21
- Last updated by the study team
- 2023-09-07
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Whole-blood specimen collected in EDTA anticoagulant tube
- Subject is 22+ years of age
- A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
- Subjects who have concurrently received CRP test results
- Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.
You may not qualify if…
- Subject is receiving an anti-IL-6 treatment
- Hemolyzed specimens
Where it is running
- University of Michigan Medical Center — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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