Enhanced Triage for COVID-19

Completed

• Conditions: SARS-CoV 2; COVID-19

• Registration Number: NCT04750369
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 806

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Cittá della Salute e della Scienza di Torino Hospital-Molinette Site; 🇮🇹 Turin, Italy

Pontifícia Universidade Católica do Rio Grande do Sul; 🇧🇷 Porto Alegre, Brazil

University Health Network; 🇨🇦 Toronto, Ontario, Canada