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

Last updated: September 5, 2023
Sponsor: Bluejay Diagnostics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT05665153
CES-0006_r2.1
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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-2positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-Bpositive by an FDA cleared test.

Exclusion

Exclusion Criteria:

  • Subject is receiving an anti-IL-6 treatment
  • Hemolyzed specimens

Study Design

Total Participants: 200
Study Start date:
November 22, 2022
Estimated Completion Date:
November 21, 2024

Connect with a study center

  • University of Michigan Medical Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.