An Approach to Screening for COVID-19 at Vancouver Airport

NCT ID: NCT04665193

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 592 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2021-04-28

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.

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.

Conditions

Asymptomatic Condition; Healthy

Study Design

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

Study Groups

Abbott Panbio test device

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

Group Type: EXPERIMENTAL

Rapid Antigen Test

Intervention Type: DIAGNOSTIC_TEST

Antigen Technology Lab-based test and Point of care test

Interventions

Rapid Antigen Test

Antigen Technology Lab-based test and Point of care test

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Abbott Rapid Diagnostics Panbio Covid-19 Ag Rapid Test Device (Nasopharyngeal)

Eligibility Criteria

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.

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vancouver Airport Authority

UNKNOWN

Sponsor Role: collaborator

WestJet Airlines

UNKNOWN

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: collaborator

KLM Royal Dutch Airlines

UNKNOWN

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Don Sin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Don Sin, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Marc Romney, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver International Airport, WestJet Domestic Terminal, Level 3

Richmond, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

H20-03225

Identifier Type: -

Identifier Source: org_study_id