Enhanced Triage for COVID-19 (ETC-19)

December 27, 2023 updated by: University Health Network, Toronto

Enhanced Triage for COVID-19 to Validate the Rapid Acute Lung Injury Diagnostic (RALI-Dx) Test

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

806

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

  • Brazil
      • Porto Alegre, Brazil
        • Pontificia Universidade Católica do Rio Grande do Sul
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
  • Italy
      • Turin, Italy
        • Cittá della Salute e della Scienza di Torino Hospital-Molinette Site

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

Sampling Method

Probability Sample

Study Population

This study aims to enroll patients 18 years or older, presenting to Emergency Rooms or COVID-19 Assessment Centers with clinical suspicion of COVID-19 infection.

Description

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

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
Predictive Accuracy of Biomarkers for Risk Stratification
Time Frame: 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.
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Performance of Biomarkers as Indicators of Clinical Severity: Disposition post-ED visit (admitted vs discharged home vs discharged home and readmitted)
Time Frame: 28 days
28 days
Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay
Time Frame: 28 days
28 days
Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS)
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

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

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 1, 2020

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-5225

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

Studies a U.S. FDA-regulated device 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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