RECRUITING

Symphony IL-6 Study in Patients at Risk of Severe Sepsis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 in a near patient setting. 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 and/or influenza infection.

Official Title

Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection

Quick Facts

Study Start:2022-11-22
Study Completion:2024-11-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05665153

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Whole-blood specimen collected in EDTA anticoagulant tube
  2. * Subject is 22+ years of age
  3. * A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
  4. * Subjects who have concurrently received CRP test results
  5. * Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.
  1. * Subject is receiving an anti-IL-6 treatment
  2. * Hemolyzed specimens

Contacts and Locations

Study Contact

Jason Cook, Ph.D.
CONTACT
9787935876
clinical@bluejaydx.com

Study Locations (Sites)

University of Michigan Medical Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2022-11-22
Study Completion Date2024-11-21

Study Record Updates

Study Start Date2022-11-22
Study Completion Date2024-11-21

Terms related to this study

Keywords Provided by Researchers

  • SIRS
  • ARDS
  • COVID-19
  • Influenza A
  • Influenza Type B
  • Respiratory Failure

Additional Relevant MeSH Terms

  • Severe Sepsis