Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

NCT05048927 — Unknown, 48 participants, Bluejay Diagnostics, Inc.

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Registry	NCT05048927
Status	Unknown
Study type	Observational
Enrollment	48 (Estimated)
Sponsor	Bluejay Diagnostics, Inc. (Industry)
Conditions	Severe Sepsis
Dates	start 2021-08-31, primary completion 2024-11-30 (estimated), completion 2024-12-31 (estimated), first posted 2021-09-17, last updated 2023-08-14
Locations	1 site in United States

-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 validate 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

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+Outcome measures

Primary outcomes

Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis [Specimen is tested within 12 hours from collection]: Validation of the established interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of severe sepsis

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Whole blood specimen collected in EDTA anticoagulant tubes
* Subject is considered to have severe or critical illness per below:

Severe Illness

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

a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criteria 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

+Locations (1)

Facility	City	Country	Status
Tina McCarthy	Acton, Texas	United States	Recruiting