SQuISH-COVID: A Pilot Study

Status unconfirmed

Conditions studied: Sepsis, COVID-19

In brief

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.

Key facts

Study ID

NCT04372472

Run by

Cytovale, Inc.

People needed

300

Starts

2020-04-07

Expected to finish

2022-04-30

Last updated by the study team

2021-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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