Testing a new device to measure IL-6 levels in patients at risk of severe sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Symphony IL-6 study aims to establish a cutoff value for interleukin-6 (IL-6) levels in patients at high risk of severe sepsis due to COVID-19 or influenza infections. This observational study utilizes the Symphony IL-6 device, which quantifies IL-6 from whole-blood specimens without the need for plasma separation. The device provides rapid results, allowing for timely clinical decision-making in emergency settings. By determining the IL-6 cutoff, the study seeks to improve the identification of patients who may develop severe sepsis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Whole-blood specimen collected in EDTA anticoagulant tube
* Subject is 22+ years of age
* A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
* Subjects who have concurrently received CRP test results
* 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.

Exclusion Criteria:

* Subject is receiving an anti-IL-6 treatment
* Hemolyzed specimens

Where it's running

• University of Michigan Medical Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Study coordinator: Jason Cook, Ph.D.
• Email: clinical@bluejaydx.com
• Phone: 9787935876

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.