An Approach to Screening for COVID-19 at Vancouver Airport
An Approach to Screening for SARS-CoV-2 at YVR: UBC-PHC-WestJet-YVR COVID-19 Screening Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
British Columbia
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Richmond、British Columbia、カナダ、V7B 0A4
- Vancouver International Airport, WestJet Domestic Terminal, Level 3
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Phase 1 Inclusion Criteria:
- The subject must be between 19 and 80 years of age.
- The subject must be a resident of B.C.
- The subject must have a ticket to board a WestJet flight departing from Vancouver International Airport (YVR).
- Have a minimum of 75 minutes of free time prior to the scheduled flight's departure.
Phase 2 Inclusion Criteria:
- Subject has access to accommodation in Canada for safe-isolation as per public health guidelines
- Between the ages of 13 - 90
- Travelling on any WestJet or KLM flight
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Abbott Panbio test device
WestJet passengers departing from YVR screened for COVID-19 using Abbott Panbio test device
|
Antigen Technology Lab-based test and Point of care test
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
COVID-19 status
時間枠：15 minutes
|
positive or negative screening result
|
15 minutes
|
協力者と研究者
協力者
捜査官
- 主任研究者：Don Sin, MD、University of British Columbia
- 主任研究者：Marc Romney, MD、University of British Columbia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。