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

NCT05665153 — Unknown, 200 participants, Bluejay Diagnostics, Inc.

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

Registry	NCT05665153
Status	Unknown
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	Bluejay Diagnostics, Inc. (Industry)
Conditions	Severe Sepsis
Dates	start 2022-11-22, primary completion 2024-08-21 (estimated), completion 2024-11-21 (estimated), first posted 2022-12-27, last updated 2023-09-07
Locations	1 site in United States

-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.

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+Outcome measures

Primary outcomes

Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation [Total duration of COVID-19 and/or influenza hospitalization, up to 1 year]: Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.

Secondary outcomes

Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay [Total duration of COVID-19 and/or influenza hospitalization, up to 1 year]: Patients hospitalized with confirmed COVID-19 and/or influenza who expire during hospital stay.
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness [Total duration of the COVID-19 hospitalization, up to 1 year]: Severe Illness (any one of the following): 1. SpO2 < 94% on room air at sea level 2. Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg 3. Respiratory frequency > 30 breaths/min 4. Or lung infiltrates >50% Critical Illness (any one of the following): 1. Respiratory failure 2. Septic shock 3. Multiple organ dysfunction

+Eligibility

Sex: All, ages: 22 Years to any

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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
University of Michigan Medical Center	Ann Arbor, Michigan	United States	Recruiting