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

Bluejay Diagnostics, Inc.200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Severe Sepsis

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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