Enhanced Triage for COVID-19

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04750369

Acronym

ETC-19

Enrollment

806

Registered

2021-02-11

Start date

2020-04-01

Completion date

2023-03-23

Last updated

2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV 2

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Brazil, Canada, Italy

Outcome results