PERC Health Canada COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05040763
• Other study ID #: REB21-1373
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2882
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

1. Age <18.0 years old

2. Presenting to a participating emergency department

3. Consented to undergo local standard of care SARS-CoV-2 test

4. 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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• Buccal Swabc- Copan flocked swab
All participants will have a buccal swab sampled collected from the inside of the mouth either by themselves or by their caregiver
• Standard of Care COVID-19 swab
All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Children's Hospital of Eastern Ontario	Hamilton	Ontario
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Children's Hospital London Health Sciences Centre	London	Ontario
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	Montreal Children's Hospital	Montréal	Quebec
Canada	Centre Hospitalier de l'Universite de Laval	Québec City	Quebec
Canada	Janeway Children's Health and Rehabilitation Centre	Saint John's	Newfoundland and Labrador
Canada	Jim Pattison Children's Hospital	Saskatoon	Saskatchewan
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Health Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Buccal Swab Clinical Sensitivity	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	Accuracy of Testing Approach	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
Secondary	Feasibility and Acceptability of Buccal Swab Collection	The study will examine the feasibility and perception of self/caregiver buccal swab sample collection	3 month recruitment timeframe