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

August 11, 2023 updated by: Bluejay Diagnostics, Inc.

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis
Time Frame: Specimen is tested within 12 hours from collection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bluejay Diagnostics, Inc.

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 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 9, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 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

Other Study ID Numbers

  • CES-0003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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