The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05060250
Recruitment Status : Active, not recruiting
First Posted : September 29, 2021
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
Bluejay Diagnostics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Severe Sepsis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Measurement of IL-6 Concentration in Patients at High Risk of Severe Sepsis [ Time Frame: Specimen is tested within 12 hours from collection ]
    Determine the interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of septic shock.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Whole-blood specimen collected in K2 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 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

Exclusion Criteria:

  • Subject is receiving an anti-IL-6 treatment
  • Subject is receiving corticosteroids
  • Hemolyzed specimens
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05060250


Locations
Layout table for location information
United States, Texas
University of Texas Southwestern Medical Center
Acton, Texas, United States, 01720
Sponsors and Collaborators
Bluejay Diagnostics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bluejay Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT05060250    
Other Study ID Numbers: CES-0002
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes