An observational study in Severe Sepsis, sponsored by Bluejay Diagnostics, Inc.. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Bluejay Diagnostics, Inc. · Observational
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.
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.
Exclusion Criteria:
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation
Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.
Time frame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay
Patients hospitalized with confirmed COVID-19 and/or influenza who expire during hospital stay.
Time frame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness
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
Time frame: Total duration of the COVID-19 hospitalization, up to 1 year
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Bluejay Diagnostics, Inc.