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NCT05048927
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
trial in Severe Sepsis in 48 participants. Status unknown.
30 November 2024
Quick facts
| Lead sponsor | Bluejay Diagnostics, Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 48 |
| Start date | 31 August 2021 |
| Primary completion | 30 November 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Conditions studied
- Severe Sepsis — all drugs for Severe Sepsis →
Sponsor
Bluejay Diagnostics, Inc.
Who can join
Adults 18 to 85, any sex, with Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05048927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Severe Sepsis
Currently open trials in the same condition.
- NCT06143137 — Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outco · recruiting
- NCT04955210 — A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children · recruiting
- NCT05413343 — Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients · active not recruiting
Other Bluejay Diagnostics, Inc. trials
Trials by the same sponsor.
- NCT07425587 — Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study · not yet recruiting
- NCT06654895 — Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study · recruiting
- NCT06181604 — Multicenter Symphony IL-6 Monitoring Sepsis ICU Study · completed
- NCT05665153 — Symphony IL-6 Study in Patients at Risk of Severe Sepsis · unknown
- NCT05060250 — Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05048927 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bluejay Diagnostics, Inc.
- Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05048927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing