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.