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

Sponsor

Bluejay Diagnostics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05665153

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 22, 2022

Anticipated Primary Completion Date :

Aug 21, 2023

Anticipated Study Completion Date :

Nov 21, 2023

Outcome Measures

Primary Outcome Measures

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

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.
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): 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

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.