- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Richmond, British Columbia, Canada, V7B 0A4
- Vancouver International Airport, WestJet Domestic Terminal, Level 3
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
COVID-19 status
Tidsramme: 15 minutes
|
positive or negative screening result
|
15 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Don Sin, MD, University of British Columbia
- Ledende efterforsker: Marc Romney, MD, University of British Columbia
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H20-03225
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Rapid Antigen Test
-
Somerset NHS Foundation TrustUkendtSARS-CoV-2 | COVIDDet Forenede Kongerige
-
HelixBind, Inc.UkendtCandidæmi | BakteriæmiForenede Stater
-
Sky Medical Supplies & Equipments, LLCRekrutteringCOVID-19 | Sars-CoV-2 infektionForenede Stater
-
Cannabis Research AssociatesIkke rekrutterer endnu
-
MP Biomedicals, LLCEDP BiotechAfsluttetCOVID-19 | SARS-CoV2-infektionForenede Stater
-
EDP BiotechParagon Rx Clinical, Inc.; iCura Diagnostics, LLCAfsluttetCOVID-19 | SARS-CoV-2 infektionForenede Stater
-
Texas Cardiac Arrhythmia Research FoundationUkendt
-
PATHIkke rekrutterer endnuPrimære immundefektsygdommePakistan
-
Polish Society of Disaster MedicineAktiv, ikke rekrutterende
-
Abbott Rapid DxBill and Melinda Gates FoundationAfsluttet