- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
British Columbia
-
Richmond, British Columbia, Canada, V7B 0A4
- Vancouver International Airport, WestJet Domestic Terminal, Level 3
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
COVID-19 status
Délai: 15 minutes
|
positive or negative screening result
|
15 minutes
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Don Sin, MD, University of British Columbia
- Chercheur principal: Marc Romney, MD, University of British Columbia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H20-03225
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .