Symphony IL-6 Study 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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05665153

Enrollment

200

Registered

2022-12-27

Start date

2022-11-22

Completion date

2024-11-21

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation	Total duration of COVID-19 and/or influenza hospitalization, up to 1 year	Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.

Secondary

Measure	Time frame	Description
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	Patients hospitalized with confirmed COVID-19 and/or influenza who expire during hospital stay.
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	Severe Illness (any one of the following): 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 (any one of the following): 1. Respiratory failure 2. Septic shock 3. Multiple organ dysfunction

Countries

United States

Contacts

Primary ContactJason Cook, Ph.D.

clinical@bluejaydx.com9787935876

Outcome results