Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19

Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis

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 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 infection.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Sepsis

• Study Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

Study Locations

• United States
  • Texas
    • Acton, Texas, United States, 01720
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will test 96 remnant, whole-blood specimens collected as baseline samples 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 polymerase chain reaction (RT-PCR) test to be COVID-19 positive. The whole-blood specimens will have been submitted to the local laboratory for routine testing.

Description

Inclusion Criteria:

• Whole-blood specimen collected in K2 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 criterion 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of IL-6 Concentration in Patients at High Risk of Severe Sepsis	Determine the interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of septic shock.	Specimen is tested within 12 hours from collection

Collaborators and Investigators

• Sponsor: Bluejay Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: CES-0002

Drug and device information, study documents

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