PERC Health Canada COVID-19

NCT05040763 | Completed DMC

• 1 other identifier: REB21-1373
• Study Type: interventional
• Target: 7,263
• Locations: 1 country
• Sites: 13

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of Testing Approach

  3 month recruitment timeframe

• Feasibility and Acceptability of Buccal Swab Collection

  3 month recruitment timeframe

Study Arms (1)

COVID-19 Swab Collection

EXPERIMENTAL

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

Diagnostic Test: Buccal Swabc- Copan flocked swab; Diagnostic Test: Standard of Care COVID-19 swab

Interventions

Buccal Swabc- Copan flocked swab DIAGNOSTIC_TEST

All participants will have a buccal swab sampled collected from the inside of the mouth either by themselves or by their caregiver

COVID-19 Swab Collection

Standard of Care COVID-19 swab DIAGNOSTIC_TEST

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

COVID-19 Swab Collection

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \. Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent.

Sponsors & Collaborators

• University of Calgary: lead
• Health Canada: collaborator

Study Sites (13)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Children's Hospital of Eastern Ontario

Hamilton, Ontario, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

Children's Hospital London Health Sciences Centre

London, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

Centre Hospitalier de l'Universite de Laval

Québec, Quebec, Canada

Location

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 39470284 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stephen Freedman, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 10, 2021
• Study Start: November 10, 2021
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: May 23, 2024

Record last verified: 2023-05

Locations

CA (13)