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SQuISH-COVID: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372472
Recruitment Status : Active, not recruiting
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Cytovale, Inc.

Brief 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.

Condition or disease
Sepsis COVID-19

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SQuISH-COVID: A Pilot Study
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

Subjects meeting the following criteria may be eligible for participation in the study:

  1. ≥ 18 years old or older
  2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
  3. 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
  4. Signs or suspicion of a respiratory infection, defined as:

    1. Subject designated for evaluation in the ED respiratory or pulmonary pod or similar location. OR
    2. An order placed for a respiratory viral panel. OR
    3. An order placed for a SARS-CoV-2 test. OR
    4. 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.

Exclusion Criteria:

Subjects are excluded from study participation if they meet any of the following criteria:

a. Blood sample volume is < 300 ul; insufficient quantity for SeptiScan testing.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372472


Locations
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United States, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Cytovale, Inc.
Biomedical Advanced Research and Development Authority
Investigators
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Principal Investigator: Hollis R O'Neal, Jr., MD, MSc Pulmonary & Critical Care LSUHSC, Baton Rouge
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Responsible Party: Cytovale, Inc.
ClinicalTrials.gov Identifier: NCT04372472    
Other Study ID Numbers: CV-CLN-003
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Cytovale, Inc.:
Sepsis
COVID
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes