SQuISH-COVID: A Pilot Study

June 14, 2021 updated by: Cytovale, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Day of enrollment through Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytovale, Inc.

Collaborators

Biomedical Advanced Research and Development Authority

Investigators

  • Principal Investigator: Hollis R O'Neal, Jr., MD, MSc, Pulmonary & Critical Care LSUHSC, Baton Rouge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Actual)

August 14, 2020

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV-CLN-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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