COVID-19NCT05040763
PERC Health Canada COVID-19
A study testing Buccal Swabc- Copan flocked swab in people with COVID-19 and SARS-CoV-2 Infection, run by University of Calgary at 13 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- Buccal Swabc- Copan flocked swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,263 participants
- Where
- 13 sitesCanada
- Study dates
- 10 Nov 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 1. Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Stollery Children's Hospital
Edmonton, Alberta
IWK Health Centre
Halifax, Nova Scotia
Children's Hospital of Eastern Ontario
Hamilton, Ontario
McMaster Children's Hospital
Hamilton, Ontario
Kingston Health Sciences Centre
Kingston, Ontario
Children's Hospital London Health Sciences Centre
London, Ontario
CHU Sainte-Justine
Montreal, Quebec
Montreal Children's Hospital
Montreal, Quebec
Centre Hospitalier de l'Universite de Laval
Québec, Quebec
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador
The Hospital for Sick Children
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
About this study
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
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.
Read the 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
- Being tested
- Buccal Swabc- Copan flocked swab, Standard of Care COVID-19 swab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Swabc- Copan flocked swabDiagnostic 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 swabDiagnostic test
All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Swab Collection | Experimental | All participants will receive standard of care COVID-19 testing in addition to buccal swab COVID-19 testing Receives: Diagnostic Test: Buccal Swabc- Copan flocked swab; Diagnostic Test: Standard of Care COVID-19 swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month recruitment timeframe
Secondary outcomes (2)
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.
Measured: 3 month recruitment timeframe
Feasibility and Acceptability of Buccal Swab Collection
The study will examine the feasibility and perception of self/caregiver buccal swab sample collection
Measured: 3 month recruitment timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start10 Nov 2021
- Primary completion30 Sep 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 7,263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Responsible party
- Sponsor
- Investigators
- Stephen Freedman, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040763
- Sponsor's protocol ID
- REB21-1373
- Status last verified
- May 2023
- First submitted
- 8 Sep 2021
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Dec 5;12(12):e0188424. doi: 10.1128/spectrum.01884-24. Epub 2024 Oct 29.
PubMed 39470284
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05040763
- Acronym / sponsor ID
- REB21-1373
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,263 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Swab Collection | Experimental | Diagnostic Test: Buccal Swabc- Copan flocked swab, Diagnostic Test: Standard of Care COVID-19 swabAll participants will receive standard of care COVID-19 testing in addition to buccal swab COVID-19 testing |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal Swabc- Copan flocked swabAll participants will have a buccal swab sampled collected from the inside of the mouth either by themselves or by their caregiver | Diagnostic test | COVID-19 Swab Collection |
| Standard of Care COVID-19 swabAll participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional | Diagnostic test | COVID-19 Swab Collection |
Primary outcome
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
2 secondary outcomes
Accuracy of Testing Approach
Time frame: 3 month recruitment timeframe
Feasibility and Acceptability of Buccal Swab Collection
Time frame: 3 month recruitment timeframe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 39470284Freedman 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 Dec 5;12(12):e0188424. doi: 10.1128/spectrum.01884-24. Epub 2024 Oct 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Freedman, MD principal investigator
University of Calgary
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal Swabc- Copan flocked swab in people with COVID-19 and SARS-CoV-2 Infection, run by University of Calgary at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal Swab Clinical Sensitivity (time frame: 3 month recruitment timeframe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.