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

ClinicalTrials.gov ID: NCT05048927

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT05048927
Recruitment status: Not listed
Study type: Observational
Phase: Not listed
Lead sponsor: Bluejay Diagnostics, Inc.; Industry
Enrollment: 48 participants

Conditions and interventions

Conditions

Severe Sepsis

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years to 85 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2021 (Actual)
Primary completion: Nov 30, 2024 (Estimated)
Completion: Dec 31, 2024 (Estimated)
Last update posted: Aug 14, 2023

2021 – 2024

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Tina McCarthy	Acton	Texas	01720	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05048927, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 14, 2023 · Synced Nov 12, 2026