Validation of a test for measuring IL-6 levels in patients at risk of severe sepsis
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
This study is testing a new quick blood test to see if it can help identify COVID-19 patients at high risk for severe sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Bluejay Diagnostics, Inc. Industry-sponsored |
| Locations | 1 site (Acton, Texas) |
| Trial ID | NCT05048927 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the cutoff value of interleukin-6 (IL-6) using the Symphony IL-6 test, which quantifies IL-6 levels from whole blood without the need for plasma separation. The Symphony IL-6 device provides rapid results, potentially allowing for point-of-care testing in emergency settings. Patients included in the study are those with severe or critical illness due to COVID-19, and the study will assess the effectiveness of the IL-6 measurement in identifying those at high risk for severe sepsis. The results could enhance early detection and management of severe sepsis in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are COVID-19 positive and exhibit signs of severe or critical illness.
Not a fit: Patients currently receiving anti-IL-6 treatment or corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and treatment of severe sepsis in COVID-19 patients.
How similar studies have performed: While the approach of using IL-6 as a biomarker has been explored, this specific validation study is novel in its application to COVID-19 related severe sepsis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Acton, Texas
- Tina McCarthy — Acton, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jason Cook, PhD
- Email: jason.cook@bluejaydx.com
- Phone: 8657429127
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.