Viewing Study NCT04896970



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Last Modification Date: 2024-10-26 @ 2:05 PM
Study NCT ID: NCT04896970
Status: WITHDRAWN
Last Update Posted: 2021-10-20
First Post: 2021-05-11

Brief Title: Risk of SARS-CoV-2 Infection COVID-19 in a Standing Concert in a Closed Performance Hall
Sponsor: University Hospital Montpellier
Organization: University Hospital Montpellier

Study Overview

Official Title: Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall
Status: WITHDRAWN
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: abandonment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ConcerTest
Brief Summary: The investigators want to compare the SARS-CoV-2 incidence 7 days after having been screened negative between two groups of adults randomized to either go to a concert or not

Participants will be screened via a rapid saliva test a few hours before the show The hypothesis is that attending a standing concert in respect of safety precaution doesnt increase the risk of SARS-CoV-2 infection
Detailed Description: Context

A previous Spanish randomized study in November 2020 concluded in a non superiority of the SARS-CoV-2 incidence in RT-PCR-negative participant of a concert compared to a control group In the same way investigators want to compare the SARS-CoV-2 incidence of participants of a concert 7 days after the show with a control group using a saliva test

While naso-pharyngeal RT-CPR is the gold-standard for virological SARS-COV-2 tests this method can be painful and results take time Saliva rapid tests have satisfactory diagnostic performances and easy access to results Saliva rapid tests may lead to mass screening in cultural mass events

This project has the specific feature to be set in closed concert hall with limited size attendance

Methodology

This experimental monocentric randomized non-inferiority will compare 2 parallel groups with single blind for the screening tests results The randomization will be centralised and stratified on the age

Program

Participants will be informed via an information notice and a preselection screening questionnaire on the internet Eligible participants will have to come on the day of the show near the concert place to be included after information and signing of the consent form participants will receive a saliva sample tube

Positively screened participants will have to go home The others will be randomized in two groups Participants will both have to come back 7 days after for the second screening

Feasibility

The concert place have a strong fan base to recruit participants from To include all the participants two concerts will take place separated by a few days Participants will receive goodies to maximize the chance of them attending to both screening

This project received a methodological support from the Clinical and Epidemiological Research Unit of the Montpellier Hospital and is promoted by the Montpellier Hospital

Sys2diag and SkillCell which developed the screening tests are involved as well as VOGO for the technical part and data management

This project is financially helped by Région Occitanie Montpellier Métropole Saint-Jean-de-Vedas SACEM APEM Tout à Fond and Boomerang

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?: None
Is an FDA AA801 Violation?: None