Status:
UNKNOWN
SQuISH-COVID: A Pilot Study
Lead Sponsor:
Cytovale, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Sepsis
COVID-19
Eligibility:
All Genders
18+ years
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 CO...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04372472
Start Date
April 7 2020
End Date
April 30 2022
Last Update
June 15 2021
Active Locations (1)
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1
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808