Recruiting

Observational Study

Sponsor:

Bluejay Diagnostics, Inc.

Code:

NCT05048927

Conditions

Severe Sepsis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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 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

Conditions

Severe Sepsis

Study ID

NCT05048927

Start date

Aug 31, 2021

Status verified date

Aug, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Nov 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis [ Time Frame: Specimen is tested within 12 hours from collection ]

Central Contacts and Locations

Central contacts

Jason Cook, PhD

8657429127jason.cook@bluejaydx.com

Locations

Tina McCarthy

Recruiting

Acton, Texas, United States, 01720

Contacts

Tina McCarthy

978-216-3022clinical@bluejaydx.com

More Information

Sponsor

Bluejay Diagnostics, Inc.

Last update posted

Aug 14, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bluejay Diagnostics, Inc. on 2023-08-14.