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

Study Overview
=================
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.

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

Conditions
-----------------
Severe Sepsis

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Total duration of COVID-19 and/or influenza hospitalization, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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): SpO2 < 94% on room air at sea level Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg Respiratory frequency > 30 breaths/min Or lung infiltrates >50% Critical Illness (any one of the following): Respiratory failure Septic shock Multiple organ dysfunction | Total duration of the COVID-19 hospitalization, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SIRS, ARDS, COVID-19, Influenza A, Influenza Type B, Respiratory Failure