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Symphony IL-6 Cutoff Validation 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 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
🗓️ Study Start (Actual) 31 August 2021
🗓️ Primary Completion (Estimated) 30 November 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 48
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Acton, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2021
  • First Submitted that Met QC Criteria 9 September 2021
  • First Posted 17 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 August 2023
  • Last Update Posted 14 August 2023
  • Last Verified August 2023
I'm interested ...!!