Asymptomatic ConditionNCT04665193
An Approach to Screening for COVID-19 at Vancouver Airport
A study testing Rapid Antigen Test in people with Asymptomatic Condition and Healthy, run by University of British Columbia at 1 site in Canada.
Trial summary
The primary objective of this pilot study is to determine the feasibility and effectiveness of a COVID-19 screening program for passengers departing from YVR. This research study is conducted by The University of British Columbia (UBC) and Providence Health Care, sponsored by WestJet and Vancouver Airport Authority. Read more about this study
- Who is it for?
- Ages 13 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition, Healthy
- What is being tested?
- Rapid Antigen Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2020to 28 Apr 2021
- 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 13 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who have previously tested positive for COVID-19 within the past 90 days
- Subjects who cannot provide written informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver International Airport, WestJet Domestic Terminal, Level 3
Richmond, British Columbia, V7B 0A4
About this study
Official title: An Approach to Screening for SARS-CoV-2 at YVR: UBC-PHC-WestJet-YVR COVID-19 Screening Study
The primary objective of this pilot study is to determine the feasibility and effectiveness of a COVID-19 screening program for passengers departing from YVR. This research study is conducted by The University of British Columbia (UBC) and Providence Health Care, sponsored by WestJet and Vancouver Airport Authority. The experimental study investigates point-of-care rapid test device for detecting SARS-CoV-2, the virus responsible for COVID-19. The study is investigating a method of rapid-testing for COVID-19 and will help inform the safest and most efficient way of testing departing passengers prior to security screening at Vancouver International Airport (YVR). This study is also evaluating a new passenger management system.
Read the detailed description
Summary of the Research Proposal
Purpose:
The purpose of this pilot study is to determine the feasibility and effectiveness of a COVID-19 screening program at YVR for WestJet and KLM passengers.
Hypothesis:
SARS-CoV-2 infection can be effectively screened using point-of-care rapid antigen assays.
Justification:
Passengers are required to wear masks and physically distance while traveling by air. However, the majority of general public is still worried about the potential risk of contracting COVID-19 on airplanes, especially during long flights. We need to develop methods and strategies to quickly screen for SARS-CoV-2 infection, prior to boarding flights.
Objectives:
- To develop and deploy a management algorithm for COVID-19 screening at YVR that will involve the use of point-of-care rapid test device.
- To evaluate the acceptability of such screening algorithm and determine the costs of deploying the program.
Research Design:
Study Population: Working in collaboration with WestJet and KLM we will invite all passengers meeting Inclusion/Exclusion on outbound flights from YVR Airport to participate in this study.
Phase 1: We will work with YVR and WestJet to enroll 200 subjects into the study. For this initial phase we are looking to determine the rate of positivity in the cohort. This initial phase is needed to evaluate the feasibility of this pilot program and to refine the initial management algorithm. Health Canada-approved Panbio Covid-19 Ag Rapid Test Device by Abbott Rapid Diagnostics (approved for Lab-based test and Point of care test on 2020-10-05) will be uses in Phase 1.
Phase 2: Strategies for achieving higher-throughput will be determined after completion of Phase 1. In phase 2, we will continue to work with YVR and WestJet, with the addition of KLM, to enroll 700 subjects into the study. Phase 2 will further assess the efficiency of our COVID-19 screening and passenger management algorithm.
The study is purposefully designed to be as minimally invasive to the passengers' travel plan as possible. The Study Plans for Phase 1 and Phase 2 are detailed below.
Statistical Analysis:
- When we aggregate the data for analysis, we will use basic statistics to determine mean, variance, standard deviation, and positivity rate...etc.
- Conditions
- Asymptomatic Condition, Healthy
- Being tested
- Rapid Antigen Test
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Antigen TestDiagnostic test
Also called Abbott Rapid Diagnostics Panbio Covid-19 Ag Rapid Test Device (Nasopharyngeal)
Antigen Technology Lab-based test and Point of care test
| Study group | Role | What they receive |
|---|---|---|
| Abbott Panbio test device | Experimental | WestJet passengers departing from YVR screened for COVID-19 using Abbott Panbio test device Receives: Diagnostic Test: Rapid Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 status
positive or negative screening result
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start23 Nov 2020
- Primary completion28 Feb 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic ConditionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Airport Authority, WestJet Airlines, Providence Health & Services, KLM Royal Dutch Airlines
- Responsible party
- Principal investigator, Don Sin, University of British Columbia
- Investigators
- Don Sin, MD, Principal investigator, University of British ColumbiaMarc Romney, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665193
- Sponsor's protocol ID
- H20-03225
- Status last verified
- Apr 2021
- First submitted
- 8 Dec 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Approach to Screening for SARS-CoV-2 at YVR: UBC-PHC-WestJet-YVR COVID-19 Screening Study
- ClinicalTrials.gov ID
- NCT04665193
- Acronym / sponsor ID
- H20-03225
- Conditions
- Asymptomatic Condition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Airport Authority, WestJet Airlines, Providence Health & Services, KLM Royal Dutch Airlines
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 11 Dec 2020 (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.
The primary objective of this pilot study is to determine the feasibility and effectiveness of a COVID-19 screening program for passengers departing from YVR. This research study is conducted by The University of British Columbia (UBC) and Providence Health Care, sponsored by WestJet and Vancouver Airport Authority. The experimental study investigates point-of-care rapid test device for detecting SARS-CoV-2, the virus responsible for COVID-19. The study is investigating a method of rapid-testing for COVID-19 and will help inform the safest and most efficient way of testing departing passengers prior to security screening at Vancouver International Airport (YVR). This study is also evaluating a new passenger management system.
Detailed description
Summary of the Research Proposal
Purpose:
The purpose of this pilot study is to determine the feasibility and effectiveness of a COVID-19 screening program at YVR for WestJet and KLM passengers.
Hypothesis:
SARS-CoV-2 infection can be effectively screened using point-of-care rapid antigen assays.
Justification:
Passengers are required to wear masks and physically distance while traveling by air. However, the majority of general public is still worried about the potential risk of contracting COVID-19 on airplanes, especially during long flights. We need to develop methods and strategies to quickly screen for SARS-CoV-2 infection, prior to boarding flights.
Objectives:
- To develop and deploy a management algorithm for COVID-19 screening at YVR that will involve the use of point-of-care rapid test device.
- To evaluate the acceptability of such screening algorithm and determine the costs of deploying the program.
Research Design:
Study Population: Working in collaboration with WestJet and KLM we will invite all passengers meeting Inclusion/Exclusion on outbound flights from YVR Airport to participate in this study.
Phase 1: We will work with YVR and WestJet to enroll 200 subjects into the study. For this initial phase we are looking to determine the rate of positivity in the cohort. This initial phase is needed to evaluate the feasibility of this pilot program and to refine the initial management algorithm. Health Canada-approved Panbio Covid-19 Ag Rapid Test Device by Abbott Rapid Diagnostics (approved for Lab-based test and Point of care test on 2020-10-05) will be uses in Phase 1.
Phase 2: Strategies for achieving higher-throughput will be determined after completion of Phase 1. In phase 2, we will continue to work with YVR and WestJet, with the addition of KLM, to enroll 700 subjects into the study. Phase 2 will further assess the efficiency of our COVID-19 screening and passenger management algorithm.
The study is purposefully designed to be as minimally invasive to the passengers' travel plan as possible. The Study Plans for Phase 1 and Phase 2 are detailed below.
Statistical Analysis:
- When we aggregate the data for analysis, we will use basic statistics to determine mean, variance, standard deviation, and positivity rate...etc.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbott Panbio test device | Experimental | Diagnostic Test: Rapid Antigen TestWestJet passengers departing from YVR screened for COVID-19 using Abbott Panbio test device |
Who may qualify
- Ages
- 13 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Rapid Antigen TestAlso: Abbott Rapid Diagnostics Panbio Covid-19 Ag Rapid Test Device (Nasopharyngeal)Antigen Technology Lab-based test and Point of care test | Diagnostic test | Abbott Panbio test device |
Primary outcome
COVID-19 status
Time frame: 15 minutes
positive or negative screening result
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 4 May 2021.
- Individual participant dataSharing planned: No
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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.
Don Sin, MD principal investigator
University of British Columbia
Marc Romney, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Antigen Test in people with Asymptomatic Condition and Healthy, run by University of British Columbia at 1 site 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 0 inclusion and 2 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
COVID-19 status (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2021.