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 Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 29, 2020
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
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.
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Cytovale, Inc.
- Biomedical Advanced Research and Development Authority
- Provider of Information About this Clinical Study
- Overall Official(s)
- Hollis R O’Neal, Jr., MD, MSc, Principal Investigator, Pulmonary & Critical Care LSUHSC, Baton Rouge
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