Severe SepsisNCT05048927
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
An observational study of Severe 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 years
- Conditions the study is for
- Severe Sepsis
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will test 48 whole blood specimens prospectively collected as baseline samples after admission from confirmed COVID-19 patients at the University of Texas Southwestern Medical Center. Subjects will be symptomatic and have been confirmed by an emergency use authorized (EUA) real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to be COVID-19 positive. The whole blood specimens will be de-identified prior to testing on the Symphony IL-6 system. Test results from the Symphony IL-6 system are investigational and are not to be used for managing patient care. The results will not be reported to health care personnel responsible for treating patients.
Who may be able to join
- Whole blood specimen collected in EDTA anticoagulant tubes
- Subject is considered to have severe or critical illness per below:
- Severe Illness
- SpO2 < 94% on room air at sea level;
- Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg;
- Respiratory frequency > 30 breaths/min;
Show all 12Show fewer
- Or lung infiltrates >50% Critical Illness
- 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
Who cannot join
- Subject is receiving an anti-IL-6 treatment
- Subject is receiving corticosteroids
- Hemolyzed specimens
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tina McCarthy
Acton, Texas, 01720
Tina McCarthy, 978-216-3022, clinical@bluejaydx.com
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.
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
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- 48 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
- NCT05048927
- Sponsor's protocol ID
- CES-0003
- 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 Cutoff Validation Study for Patients at Risk of Severe Sepsis
- ClinicalTrials.gov ID
- NCT05048927
- Acronym / sponsor ID
- CES-0003
- Conditions
- Severe Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bluejay Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will test 48 whole blood specimens prospectively collected as baseline samples after admission from confirmed COVID-19 patients at the University of Texas Southwestern Medical Center. Subjects will be symptomatic and have been confirmed by an emergency use authorized (EUA) real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to be COVID-19 positive. The whole blood specimens will be de-identified prior to testing on the Symphony IL-6 system. Test results from the Symphony IL-6 system are investigational and are not to be used for managing patient care. The results will not be reported to health care personnel responsible for treating patients.
Key inclusion criteria (12 listed)
- Whole blood specimen collected in EDTA anticoagulant tubes
- Subject is considered to have severe or critical illness per below:
- Severe Illness
- SpO2 < 94% on room air at sea level;
- Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg;
Key exclusion criteria (3 listed)
- Subject is receiving an anti-IL-6 treatment
- Subject is receiving corticosteroids
- 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
Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis
Time frame: Specimen is tested within 12 hours from collection
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
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 Severe 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 12 inclusion and 3 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 (8657429127, jason.cook@bluejaydx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). 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; AzTrials last refreshed its copy on 29 Oct 2026.