Enhanced Triage for COVID-19

NCT04750369 | Completed

• 1 other identifier: 20-5225
• Study Type: observational
• Target: 806
• Locations: 3 countries
• Sites: 3

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.

Conditions

COVID-19; SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Brazil

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Cittá della Salute e della Scienza di Torino Hospital-Molinette Site

Turin, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample will be collected in an EDTA tube for biomarker analysis.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shahid Husain, MD MS

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: April 1, 2020
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); BR (1); CA (1)