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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048927
• Other study ID #: CES-0003
• Status: Recruiting
• Start date: August 31, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Bluejay Diagnostics, Inc.
• Contact: Jason Cook, PhD
• Phone: 8657429127
• Email: jason.cook[@]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 as a point-of-care (POC) device.

This study is to validate 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Whole blood specimen collected in 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 criteria 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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Tina McCarthy	Acton	Texas

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	Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis	Validation of the established interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of severe sepsis	Specimen is tested within 12 hours from collection