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

NCT05665153 | Unknown

• 1 other identifier: CES-0006_r2.1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Severe Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation

  Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.

  Total duration of COVID-19 and/or influenza hospitalization, up to 1 year

Secondary Outcomes (2)

• Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay

  Total duration of COVID-19 and/or influenza hospitalization, up to 1 year

• Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness

  Total duration of the COVID-19 hospitalization, up to 1 year

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll approximately 200 individuals, whole-blood specimens collected as baseline samples from hospitalized individuals with confirmed COVID-19 and/or influenza patients at the University of Michigan Medical Center, Ann Arbor, MI.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bluejay Diagnostics, Inc.: lead

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Sepsis; COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Jason Cook, Ph.D.

CONTACT

9787935876; clinical@bluejaydx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 27, 2022
• Study Start: November 22, 2022
• Primary Completion: August 21, 2024
• Study Completion: November 21, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)