Trials / Unknown
UnknownNCT05048927
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 48 (estimated)
- Sponsor
- Bluejay Diagnostics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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 as a point-of-care (POC) device. This study is to validate 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 infection
Conditions
Timeline
- Start date
- 2021-08-31
- Primary completion
- 2024-11-30
- Completion
- 2024-12-31
- First posted
- 2021-09-17
- Last updated
- 2023-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05048927. Inclusion in this directory is not an endorsement.