Enhanced Triage for COVID-19

COVID-19 Clinical Trial

— ETC-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750369
• Other study ID #: 20-5225
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Locations

Country	Name	City	State
Brazil	Pontifícia Universidade Católica do Rio Grande do Sul	Porto Alegre
Canada	University Health Network	Toronto	Ontario
Italy	Cittá della Salute e della Scienza di Torino Hospital-Molinette Site	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Countries where clinical trial is conducted

Brazil,  Canada,  Italy, 

Outcome

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