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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665153
• Other study ID #: CES-0006_r2.1
• Status: Recruiting
• Start date: November 22, 2022
• Est. completion date: November 21, 2024

Study information

• Verified date: September 2023
• Source: Bluejay Diagnostics, Inc.
• Contact: Jason Cook, Ph.D.
• Phone: 9787935876
• Email: clinical[@]bluejaydx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 21, 2024
• Est. primary completion date: August 21, 2024
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bluejay Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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