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SQuISH-COVID: A Pilot Study

C

Cytovale

Status

Unknown

Conditions

COVID-19
Sepsis

Study type

Observational

Funder types

Industry
Other U.S. Federal agency

Identifiers

NCT04372472
CV-CLN-003

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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