Clinical trial NCT05040763: PERC Health Canada COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
SARS-CoV-2 Infection
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2021-09-10
Enrollment: 7263
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The primary objective of this study is to determine whether buccal swabs analyzed with the Abbott ID Now perform acceptably compared to standard of care COVID-19 swabs
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Buccal Swab Clinical Sensitivity
timeFrame: 3 month recruitment timeframe
Secondary outcomes:
measure: Accuracy of Testing Approach
timeFrame: 3 month recruitment timeframe
measure: Feasibility and Acceptability of Buccal Swab Collection
timeFrame: 3 month recruitment timeframe
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Saint John's
country: Canada
facility: Janeway Children's Health and Rehabilitation Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Children's Hospital London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Québec City
country: Canada
facility: Centre Hospitalier de l'Universite de Laval
state: Quebec
city: Saskatoon
country: Canada
facility: Jim Pattison Children's Hospital
state: Saskatchewan
Study officials:
affiliation: University of Calgary
name: Stephen Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References: