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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05048927
Other study ID # CES-0003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 31, 2021
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source Bluejay Diagnostics, Inc.
Contact Jason Cook, PhD
Phone 8657429127
Email jason.cook@bluejaydx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 validate 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


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 31, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Tina McCarthy Acton Texas

Sponsors (1)

Lead Sponsor Collaborator
Bluejay Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis Validation of the established interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of severe sepsis Specimen is tested within 12 hours from collection
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