SQuISH-COVID: A Pilot Study

NCT04372472 | Unknown

• 1 other identifier: CV-CLN-003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; COVID-19

Keywords

Sepsis; COVID

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll up to 300 participants from the emergency department at one clinical research site. Subjects who are suspected of having COVID-19 or other infectious respiratory diseases may be eligible for the study.

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.

Sponsors & Collaborators

• Cytovale, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Sepsis; COVID-19

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hollis R O'Neal, Jr., MD, MSc

  Pulmonary & Critical Care LSUHSC, Baton Rouge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: April 7, 2020
• Primary Completion: August 14, 2020
• Study Completion: April 30, 2022
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)