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ETC-19: Enhanced Triage for COVID-19

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04750369
Collaborator
(none)
400
Enrollment
1
Location
33
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate of the accuracy of biomarkers (i.e. circulating endothelial and immune activation markers) that indicate progression to severe disease in patients with suspected COVID-19 in the Emergency Department. It is a prospective observational study of patients presenting to emergency departments with a clinical suspicion of COVID19. All participants will have plasma samples collected for biomarker analysis, and will be tested for SARS-CoV-2 infection with a nasopharyngeal swab. Participants will be managed according to the best local practices.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Enhanced Triage for COVID-19 to Validate the Rapid Acute Lung Injury Diagnostic (RALI-Dx) Test
    Actual Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Predictive Accuracy of Biomarkers for Risk Stratification [28 days]

      Given the expected clinical utility, we will use likelihood ratios (LRs) as our target milestone. +LR = (test sensitivity)/(1-test specificity); -LR= (1- sensitivity)/specificity. We will conservatively target benchmarks of +LR>5 for a disposition towards and a -LR<0.1 for a disposition away from mortality risk.

    Secondary Outcome Measures

    1. Performance of Biomarkers as Indicators of Clinical Severity: Disposition post-ED visit (admitted vs discharged home vs discharged home and readmitted) [28 days]

    2. Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay [28 days]

    3. Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS) [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients presenting with clinical suspicion of COVID-19 infection, as per UHN case definition at the time of presentation

    • Age >18 years

    • Ability to provide verbal informed consent

    Exclusion Criteria:
    • Patients who are not suspected of COVID-19 infection, as per UHN definition at the time of presentation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada M5G 2C4

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Shahid Husain, MD MS, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT04750369
    Other Study ID Numbers:
    • 20-5225
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 11, 2022