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Clinical Trial Summary

Although there are several licensed vaccines for SAR-CoV-2 (COVID-19) in Canada, none of them are approved for use in children under the age of 12, leaving five million children under 12 years unvaccinated. There is a need to find methods of mass rapid point of care testing in unvaccinated populations such as in schools that can be performed by a lay individual. This multi-center study will evaluate the clinical sensitivity of buccal swabs with the ID NOW COVID-19 device in comparison to standard of care COVID-19 testing at 15 pediatric emergency centres across Canada.

Clinical Trial Description

This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as determined by the clinical care team. The study also seeks to identify factors that influence the accuracy of the testing approach and to examine the feasibility and perception of self/caregiver buccal swab sample collection. In this prospective study, we will compare the Abbott ID NOW COVID-19 device with the reference gold standard nasal, nasopharyngeal (NP) or throat swabs as the deemed standard of care at participating sites and with specimens collected by a qualified health professional and assessed by local laboratory services. Individuals presenting to the emergency department that are identified as meeting the criteria as per local guidelines to be tested for SARS-CoV-2 (i.e. droplet precautions) will be appropriately consented and screened for participation in the study. Eligible consented participants will have their past medical history, COVID-19 symptom assessment, vaccination status, and physical exam findings collected from their charts. A qualified healthcare professional will obtain a standard of care RT-PCT Swab from the participant. The results from this swab will be collected from the participants chart once available. Depending on age, the study team will then train the participant/caregiver how to perform and obtain a buccal swab from the inside of the cheek. The collected buccal swab will be analyzed by the study team using the Abbott ID NOW COVID-19 device and results obtained within approx 15 mins. Participants and their families will be notified of the qualitative result from the buccal swab. Participants and their caregivers will be asked to complete pain assessment and acceptability questionnaires for both the standard of care and buccal swab tests. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05040763
Study type Interventional
Source University of Calgary
Contact Stephen Freedman, MD
Phone (403) 955-7740
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 1, 2021
Completion date May 31, 2022

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