Clinical trial NCT05048927: Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
Official title: Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Sepsis
Lead sponsor: Bluejay Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will test 48 whole blood specimens prospectively collected as baseline samples after admission from confirmed COVID-19 patients at the University of Texas Southwestern Medical Center. Subjects will be symptomatic and have been confirmed by an emergency use authorized (EUA) real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to be COVID-19 positive.

The whole blood specimens will be de-identified prior to testing on the Symphony IL-6 system. Test results from the Symphony IL-6 system are investigational and are not to be used for managing patient care. The results will not be reported to health care personnel responsible for treating patients.

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis
timeFrame: Specimen is tested within 12 hours from collection
Secondary outcomes:
Other outcomes:
Locations:
city: Acton
country: United States
facility: Tina McCarthy
state: Texas
Study officials:
References: