Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19

Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05060250

Enrollment

Registered

2021-09-29

Start date

2021-08-31

Completion date

2024-12-31

Last updated

2023-08-15

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

Conditions

Severe Sepsis

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 as a point-of-care (POC) device. 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 infection.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Whole-blood specimen collected in K2 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 criterion 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

Design outcomes

Primary

Measure	Time frame	Description
Measurement of IL-6 Concentration in Patients at High Risk of Severe Sepsis	Specimen is tested within 12 hours from collection	Determine the interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of septic shock.

Countries

United States

Outcome results