- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040763
PERC Health Canada COVID-19
A Multi-Center Evaluation of Buccal Swabs With the Abbott ID NOW COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 validate a self collected buccal swab that is analyzed with the Abbott ID NOW COVID-19 device against a reference RT-PCR nasal, nasopharyngeal (NP) or throat swab (or others) deemed standard of care at participating sites. The standard of care swabs will be 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-PCR 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alberta
-
Edmonton, Alberta, Canada
- Stollery Children's Hospital
-
-
British Columbia
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Vancouver, British Columbia, Canada
- BC Children's Hospital
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-
Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada
- Janeway Children's Health and Rehabilitation Centre
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada
- Children's Hospital of Eastern Ontario
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Hamilton, Ontario, Canada
- McMaster Children's Hospital
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Kingston, Ontario, Canada
- Kingston Health Sciences Centre
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London, Ontario, Canada
- Children's Hospital London Health Sciences Centre
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Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Quebec
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Montréal, Quebec, Canada
- Montreal Children's Hospital
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Montréal, Quebec, Canada
- CHU Sainte-Justine
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Québec City, Quebec, Canada
- Centre Hospitalier de l'Universite de Laval
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Jim Pattison Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age <18.0 years old
- Presenting to a participating emergency department
- Consented to undergo local standard of care SARS-CoV-2 test
- Able to read/speak English or French
Exclusion Criteria:
1. Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COVID-19 Swab Collection
All participants will receive standard of care COVID-19 testing in addition to buccal swab COVID-19 testing
|
All participants will have a buccal swab sampled collected from the inside of the mouth either by themselves or by their caregiver
All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Buccal Swab Clinical Sensitivity
Time Frame: 3 month recruitment timeframe
|
The study will evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19 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 compared to standard of care reference standard COVID-19 swab testing
|
3 month recruitment timeframe
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of Testing Approach
Time Frame: 3 month recruitment timeframe
|
The team will Identify factors which influence the accuracy of testing such as symptoms onset, duration of symptoms, age, past medical history, vaccination status etc.
|
3 month recruitment timeframe
|
Feasibility and Acceptability of Buccal Swab Collection
Time Frame: 3 month recruitment timeframe
|
The study will examine the feasibility and perception of self/caregiver buccal swab sample collection
|
3 month recruitment timeframe
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Freedman, MD, University Of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB21-1373
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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