Enhanced Triage for COVID-19

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.

Completed

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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
Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: ETC-19

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Feb 11, 2021
Registry last updated: Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed