SepsisNCT05048888
Symphony IL-6 Reference Range Study
An observational study of Sepsis, run by Bluejay Diagnostics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll approximately 120 apparently healthy individuals, split approximately between males and females, and covering an age range from approximately 18 to 85 years of age at the University of Texas Southwestern Medical Center, or from satellite facilities associated with the medical center. Subjects must meet all eligibility criteria to be in enrolled in the study. Whole blood specimens will be prospectively collected and tested using the Symphony IL-6 system.
Who may be able to join
- Subject is willing and able to provide informed consent
- > 18 years of age
- Whole blood specimen collected in EDTA anticoagulant tubes
- Minimum volume of 100µL for Symphony IL-6 testing
- Specimen is available for testing within 12 hours from collection
- C-Reactive Protein (CRP) < 10 mg/L
Who cannot join
- Subjects presenting with a fever
- Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection
- Subjects otherwise self-reported as unhealthy
- Hemolyzed specimens
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Madhusudhanan Narasimhan, PhD, MSHA, 214-645-5142, madhusudhanan.narasimhan@utsouthwestern.edu
About this study
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.
The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Reference Range Study
Establishment of the interleukin-6 concentration in whole blood samples from healthy individuals.
Measured: Specimen is tested within 12 hours from collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start31 Aug 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bluejay Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048888
- Sponsor's protocol ID
- CES-0001
- Status last verified
- Aug 2023
- First submitted
- 9 Sep 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symphony IL-6 Reference Range Study
- ClinicalTrials.gov ID
- NCT05048888
- Acronym / sponsor ID
- CES-0001
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bluejay Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll approximately 120 apparently healthy individuals, split approximately between males and females, and covering an age range from approximately 18 to 85 years of age at the University of Texas Southwestern Medical Center, or from satellite facilities associated with the medical center. Subjects must meet all eligibility criteria to be in enrolled in the study. Whole blood specimens will be prospectively collected and tested using the Symphony IL-6 system.
Key inclusion criteria (6 listed)
- Subject is willing and able to provide informed consent
- > 18 years of age
- Whole blood specimen collected in EDTA anticoagulant tubes
- Minimum volume of 100µL for Symphony IL-6 testing
- Specimen is available for testing within 12 hours from collection
Key exclusion criteria (4 listed)
- Subjects presenting with a fever
- Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection
- Subjects otherwise self-reported as unhealthy
- Hemolyzed specimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL-6 Reference Range Study
Time frame: Specimen is tested within 12 hours from collection
Establishment of the interleukin-6 concentration in whole blood samples from healthy individuals.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Bluejay Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Cook, PhD (844-327-7078, jason.cook@bluejaydx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 Reference Range Study (time frame: Specimen is tested within 12 hours from collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.