Severe SepsisNCT05665153
Symphony IL-6 Study in 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 22 years and older
- Conditions the study is for
- Severe Sepsis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 21 Nov 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 22 years and older
- All sexes
- Adult, Older adult
Study population: We will enroll approximately 200 individuals, whole-blood specimens collected as baseline samples from hospitalized individuals with confirmed COVID-19 and/or influenza patients at the University of Michigan Medical Center, Ann Arbor, MI.
Who may be able to join
- Whole-blood specimen collected in EDTA anticoagulant tube
- Subject is 22+ years of age
- A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
- Subjects who have concurrently received CRP test results
- Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.
Who cannot join
- Subject is receiving an anti-IL-6 treatment
- Hemolyzed specimens
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Tina McCarthy, clinical@bluejaydx.com
About this study
Official title: Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection
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 in a near patient setting.
This study is to establish 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 and/or influenza infection.
- Conditions
- Severe Sepsis
- Keywords
- SIRS, ARDS, COVID-19, Influenza A, Influenza Type B, Respiratory Failure
- Medical subject headings
- Sepsis, COVID-19, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation
Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.
Measured: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Secondary outcomes (2)
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay
Patients hospitalized with confirmed COVID-19 and/or influenza who expire during hospital stay.
Measured: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness
Severe Illness (any one of the following):
- 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
- Or lung infiltrates >50%
Critical Illness (any one of the following):
- Respiratory failure
- Septic shock
- Multiple organ dysfunction
Measured: Total duration of the COVID-19 hospitalization, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start22 Nov 2022
- Primary completion21 Aug 2024 (estimated)
- Study completion21 Nov 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
- 200 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
- NCT05665153
- Sponsor's protocol ID
- CES-0006_r2.1
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection
- ClinicalTrials.gov ID
- NCT05665153
- Acronym / sponsor ID
- CES-0006_r2.1
- Conditions
- Severe Sepsis
- Keywords
- SIRS, ARDS, COVID-19, Influenza A, Influenza Type B, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bluejay Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 21 Aug 2024 (estimated)
- Study completion
- 21 Nov 2024 (estimated)
- First posted
- 27 Dec 2022 (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 in a near patient setting.
This study is to establish 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 and/or influenza infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will enroll approximately 200 individuals, whole-blood specimens collected as baseline samples from hospitalized individuals with confirmed COVID-19 and/or influenza patients at the University of Michigan Medical Center, Ann Arbor, MI.
Key inclusion criteria (5 listed)
- Whole-blood specimen collected in EDTA anticoagulant tube
- Subject is 22+ years of age
- A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
- Subjects who have concurrently received CRP test results
- Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.
Key exclusion criteria (2 listed)
- Subject is receiving an anti-IL-6 treatment
- 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
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation
Time frame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.
2 secondary outcomes
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay
Time frame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness
Time frame: Total duration of the COVID-19 hospitalization, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 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 5 inclusion and 2 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 7 Sep 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, Ph.D. (9787935876, clinical@bluejaydx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation (time frame: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year). 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 7 Sep 2023.