SepsisNCT04372472
SQuISH-COVID: A Pilot Study
An observational study of Sepsis and COVID-19, run by Cytovale, Inc. at 1 site in United States.
Trial summary
This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2020to 30 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll up to 300 participants from the emergency department at one clinical research site. Subjects who are suspected of having COVID-19 or other infectious respiratory diseases may be eligible for the study.
Who may be able to join
- Subjects meeting the following criteria may be eligible for participation in the study:
- ≥ 18 years old or older
- The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
- A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded
- Signs or suspicion of a respiratory infection, defined as:
- Subject designated for evaluation in the ED respiratory or pulmonary pod or similar location. OR
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- An order placed for a respiratory viral panel. OR
- An order placed for a SARS-CoV-2 test. OR
- A subject self-reported as having tested positive for the SARS-CoV-2 test within the previous 7 days and returning with a related complaint.
Who cannot join
- Subjects are excluded from study participation if they meet any of the following criteria:
- Blood sample volume is < 300 ul; insufficient quantity for SeptiScan testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
About this study
This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.
- Keywords
- Sepsis, COVID
- Medical subject headings
- Sepsis, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection.
The SeptiScan System is an investigational microfluidic assay that measures the biophysical properties of human leukocytes as an aid, in conjunction with other clinical assessments, to detect life-threatening organ dysfunction caused by a dysregulated host immune response to infection. The SeptiScan System score is presented in three Interpretation Bands of low, intermediate, and high probability of disease. Remnant blood samples will be obtained from subjects in Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. The blood samples will be analyzed using the SeptiScan System.
Measured: Day of enrollment through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start7 Apr 2020
- Primary completion14 Aug 2020
- Study completion30 Apr 2022 (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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytovale, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Hollis R O'Neal, Jr., MD, MSc, Principal investigator, Pulmonary & Critical Care LSUHSC, Baton Rouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372472
- Sponsor's protocol ID
- CV-CLN-003
- Status last verified
- Jun 2021
- First submitted
- 29 Apr 2020
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SQuISH-COVID: A Pilot Study
- ClinicalTrials.gov ID
- NCT04372472
- Acronym / sponsor ID
- CV-CLN-003
- Keywords
- Sepsis, COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cytovale, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 4 May 2020 (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.
This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll up to 300 participants from the emergency department at one clinical research site. Subjects who are suspected of having COVID-19 or other infectious respiratory diseases may be eligible for the study.
Key inclusion criteria (9 listed)
- ≥ 18 years old or older
- The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
- A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded
- Signs or suspicion of a respiratory infection, defined as:
Key exclusion criteria (2 listed)
- Subjects are excluded from study participation if they meet any of the following criteria:
- Blood sample volume is < 300 ul; insufficient quantity for SeptiScan testing.
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
To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection.
Time frame: Day of enrollment through Day 5
The SeptiScan System is an investigational microfluidic assay that measures the biophysical properties of human leukocytes as an aid, in conjunction with other clinical assessments, to detect life-threatening organ dysfunction caused by a dysregulated host immune response to infection. The SeptiScan System score is presented in three Interpretation Bands of low, intermediate, and high probability of disease. Remnant blood samples will be obtained from subjects in Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. The blood samples will be analyzed using the SeptiScan System.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Hollis R O'Neal, Jr., MD, MSc principal investigator
Pulmonary & Critical Care LSUHSC, Baton Rouge
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 and COVID-19, run by Cytovale, 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 9 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 15 Jun 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection. (time frame: Day of enrollment through Day 5). 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 15 Jun 2021.