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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Sepsis

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jason Cook, Ph.D.; Phone Number: 9787935876; Email: clinical@bluejaydx.com

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Medical Center
      • Contact: Tina McCarthy; Email: clinical@bluejaydx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

We will enroll approximately 200 individuals, whole-blood specimens collected as baseline samples from hospitalized individuals with confirmed COVID-19 and/or influenza patients at the University of Michigan Medical Center, Ann Arbor, MI.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bluejay Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): August 21, 2024
• Study Completion (Estimated): November 21, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; SIRS; Influenza A; Respiratory Failure; Influenza Type B
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: CES-0006_r2.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No