SQuISH-COVID: A Pilot Study

COVID-19 Clinical Trial

Official title:

SQuISH-COVID: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04372472
• Other study ID #: CV-CLN-003
• Status: Active, not recruiting
• Start date: April 7, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2021
• Source: Cytovale, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 30, 2022
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sepsis

Locations

Country	Name	City	State
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Cytovale, Inc.	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Day of enrollment through Day 5