SQuISH-COVID: A Pilot Study
Purpose
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.
Conditions
- Sepsis
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- NCT ID
- NCT04372472
- Status
- Unknown status
- Sponsor
- Cytovale, Inc.