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

NCT05060250 | Unknown

• 1 other identifier: CES-0002
• Study Type: observational
• Target: 96
• 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 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.

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

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 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.

You may qualify if:

• Whole-blood specimen collected in K2 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 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

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)

University of Texas Southwestern Medical Center

Acton, Texas, 01720, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

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 29, 2021
• Study Start: August 31, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

US (1)