SQuISH-COVID: A Pilot Study

• Conditions: Sepsis; COVID-19

• Registration Number: NCT04372472
• Lead Sponsor: Cytovale, Inc.

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 COVID-19 or other infectious respiratory diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-07
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-04
• Primary Completion: 2020-08-14
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-15
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection.	Day of enrollment through Day 5	The SeptiScan System is an investigational microfluidic assay that measures the biophysical properties of human leukocytes as an aid, in conjunction with other clinical assessments, to detect life-threatening organ dysfunction caused by a dysregulated host immune response to infection. The SeptiScan System score is presented in three Interpretation Bands of low, intermediate, and high probability of disease. Remnant blood samples will be obtained from subjects in Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. The blood samples will be analyzed using the SeptiScan System.

Trial Locations

Locations (1)

Our Lady of the Lake Regional Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States