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

NCT05048927 | Unknown

• 1 other identifier: CES-0003
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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 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

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will test 48 whole blood specimens prospectively collected as baseline samples after admission 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 reverse transcriptase polymerase chain reaction (RT-PCR) test to be COVID-19 positive. The whole blood specimens will be de-identified prior to testing on the Symphony IL-6 system. Test results from the Symphony IL-6 system are investigational and are not to be used for managing patient care. The results will not be reported to health care personnel responsible for treating patients.

You may qualify if:

• Whole blood specimen collected in EDTA anticoagulant tubes
• Subject is considered to have severe or critical illness per below:
• Severe Illness
• 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
• 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

You may not qualify if:

• Subject is receiving an anti-IL-6 treatment
• Subject is receiving corticosteroids
• Hemolyzed specimens

Sponsors & Collaborators

• Bluejay Diagnostics, Inc.: lead

Study Sites (1)

Tina McCarthy

Acton, Texas, 01720, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jason Cook, PhD

CONTACT

8657429127; jason.cook@bluejaydx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: August 31, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)