Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bluejay Diagnostics, Inc.
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Measurement of IL-6 Concentration in Patients at High 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 as a point-of-care (POC) device.
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 infection.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Whole-blood specimen collected in K2 EDTA anticoagulant tubes
- •Subject is considered to have severe or critical illness per below:
- •Severe Illness
- •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
- •a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criterion of severe illness
- •Subject confirmed to be COVID-19 positive by an EUA RT-PCR test
- •Subject is 18+ years of age
- •Minimum volume of 100µL for Symphony IL-6 testing
- •Specimen is available for testing within 12 hours from collection
Exclusion Criteria
- •Subject is receiving an anti-IL-6 treatment
- •Subject is receiving corticosteroids
- •Hemolyzed specimens
Outcomes
Primary Outcomes
Measurement of IL-6 Concentration in Patients at High Risk of Severe Sepsis
Time Frame: Specimen is tested within 12 hours from collection
Determine the interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of septic shock.
Secondary Outcomes
No secondary outcomes reported