Clinical trial NCT05665153: Symphony IL-6 Study in Patients at Risk of Severe Sepsis
Official title: Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Sepsis
Keywords: SIRS
ARDS
COVID-19
Influenza A
Influenza Type B
Respiratory Failure
Lead sponsor: Bluejay Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll approximately 200 individuals, whole-blood specimens collected as baseline samples from hospitalized individuals with confirmed COVID-19 and/or influenza patients at the University of Michigan Medical Center, Ann Arbor, MI.

Brief 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 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

Primary outcomes:
measure: Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation
timeFrame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Secondary outcomes:
measure: Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay
timeFrame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
measure: Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness
timeFrame: Total duration of the COVID-19 hospitalization, up to 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
References: