PERC Health Canada COVID-19

NCT ID: NCT05040763

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2023-03-31

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

COVID-19 Swab Collection

All participants will receive standard of care COVID-19 testing in addition to buccal swab COVID-19 testing

Group Type: EXPERIMENTAL

Buccal Swabc- Copan flocked swab

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Standard of Care COVID-19 swab

All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional

Intervention Type: DIAGNOSTIC_TEST

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Canada

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Stollery Children's Hospital

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, 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

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Centre Hospitalier de l'Universite de Laval

Québec, Quebec, Canada

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Freedman SB, Kim K, Freire G, Kanngiesser A, Kam A, Doan Q, Wright B, Bhatt M, Berthelot S, Gravel J, Burstein B, Emsley J, Mater A, Porter R, Poonai N, Reddy D, Webster RJ, Goldfarb DM, Leifso K, Zemek R; Pediatric Emergency Research Canada (PERC) COVID Study Group. Accuracy of point-of-care SARS-CoV-2 detection using buccal swabs in pediatric emergency departments. Microbiol Spectr. 2024 Oct 29;12(12):e0188424. doi: 10.1128/spectrum.01884-24. Online ahead of print.

Reference Type: DERIVED

PMID: 39470284 (View on PubMed)

Other Identifiers

REB21-1373

Identifier Type: -

Identifier Source: org_study_id