An Approach to Screening for COVID-19 at Vancouver Airport

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT04665193
Collaborator
Vancouver Airport Authority (Other), WestJet Airlines (Other), Providence Health & Services (Other), KLM Royal Dutch Airlines (Other)
592
1
1
5.1
115.5

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Rapid Antigen Test
N/A

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:
  1. 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.

  2. 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

Study Type:
Interventional
Actual Enrollment :
592 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
An Approach to Screening for SARS-CoV-2 at YVR: UBC-PHC-WestJet-YVR COVID-19 Screening Study
Actual Study Start Date :
Nov 23, 2020
Actual Primary Completion Date :
Feb 28, 2021
Actual Study Completion Date :
Apr 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abbott Panbio test device

WestJet passengers departing from YVR screened for COVID-19 using Abbott Panbio test device

Diagnostic Test: Rapid Antigen Test
Antigen Technology Lab-based test and Point of care test
Other Names:
  • Abbott Rapid Diagnostics Panbio Covid-19 Ag Rapid Test Device (Nasopharyngeal)
  • Outcome Measures

    Primary Outcome Measures

    1. COVID-19 status [15 minutes]

      positive or negative screening result

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Phase 1 Inclusion Criteria:
    1. The subject must be between 19 and 80 years of age.

    2. The subject must be a resident of B.C.

    3. The subject must have a ticket to board a WestJet flight departing from Vancouver International Airport (YVR).

    4. Have a minimum of 75 minutes of free time prior to the scheduled flight's departure.

    Phase 2 Inclusion Criteria:
    1. Subject has access to accommodation in Canada for safe-isolation as per public health guidelines

    2. Between the ages of 13 - 90

    3. Travelling on any WestJet or KLM flight

    4. Have a minimum of 70 minutes (if travelling within Canada) or 90 minutes (if travelling International) of free time prior to the schedule flight's departure


    Exclusion Criteria:
    • Subjects who have previously tested positive for COVID-19 within the past 90 days

    • Subjects who cannot provide written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vancouver International Airport, WestJet Domestic Terminal, Level 3 Richmond British Columbia Canada V7B 0A4

    Sponsors and Collaborators

    • University of British Columbia
    • Vancouver Airport Authority
    • WestJet Airlines
    • Providence Health & Services
    • KLM Royal Dutch Airlines

    Investigators

    • Principal Investigator: Don Sin, MD, University of British Columbia
    • Principal Investigator: Marc Romney, MD, University of British Columbia

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Don Sin, Professor, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT04665193
    Other Study ID Numbers:
    • H20-03225
    First Posted:
    Dec 11, 2020
    Last Update Posted:
    May 4, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2021