Testing a new device to measure IL-6 levels in patients at risk of severe sepsis
Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection
This study is testing a new device that quickly measures IL-6 levels in patients at risk of severe sepsis from COVID-19 or influenza to help doctors make faster decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Bluejay Diagnostics, Inc. Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05665153 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22 and older who are confirmed positive for COVID-19 or influenza and have had a CRP test.
Not a fit: Patients receiving anti-IL-6 treatment or those with hemolyzed blood specimens will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management of severe sepsis in at-risk patients, potentially improving outcomes.
How similar studies have performed: Other studies have shown promise in using IL-6 as a biomarker for severe sepsis, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.