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Enhanced Triage for COVID-19

NCT ID: NCT04750369

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

806 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-03-23

Brief Summary

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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

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Conditions

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COVID-19 SARS-CoV 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shahid Husain, MD MS

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, , Brazil

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

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

Turin, , Italy

Site Status

Countries

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Brazil Canada Italy

Other Identifiers

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20-5225

Identifier Type: -

Identifier Source: org_study_id