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

Recruiting

• Conditions: Severe Sepsis

• Registration Number: NCT05665153
• Lead Sponsor: Bluejay Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-22
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-08-21
• Study Completion: 2024-11-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation	Total duration of COVID-19 and/or influenza hospitalization, up to 1 year	Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.

Secondary Outcome Measures

Name	Time	Method
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness	Total duration of the COVID-19 hospitalization, up to 1 year	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
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay	Total duration of COVID-19 and/or influenza hospitalization, up to 1 year	Patients hospitalized with confirmed COVID-19 and/or influenza who expire during hospital stay.

Trial Locations

Locations (1)

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States