- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04665193
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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British Columbia
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Richmond, British Columbia, 캐나다, V7B 0A4
- Vancouver International Airport, WestJet Domestic Terminal, Level 3
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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COVID-19 status
기간: 15 minutes
|
positive or negative screening result
|
15 minutes
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Don Sin, MD, University of British Columbia
- 수석 연구원: Marc Romney, MD, University of British Columbia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .