Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665193
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2020-12-08
Brief Title:
An Approach to Screening for COVID-19 at Vancouver Airport
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
An Approach to Screening for SARS-CoV-2 at YVR UBC-PHC-WestJet-YVR COVID-19 Screening Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 InclusionExclusion 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 rateetc
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 InclusionExclusion 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 rateetc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None