Risk of SARS-CoV-2 Infection (COVID-19) in a Standing Concert in a Closed Performance Hall (ConcerTest)

University Hospital Center (CHU)

Status

Withdrawn

Conditions

SARS-CoV-2

Treatments

Other: Concert

Study type

Interventional

Funder types

Other

Identifiers

NCT04896970

RECHMPL21_0110

Details and patient eligibility

About

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 doesn't increase the risk of SARS-CoV-2 infection.

Full 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.

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

At least 18 and less than 60 years old
Having completed the internet pre selection questionnaire and signed the consent form
Negative rapid saliva RT-LAMP EasyCov test on the day of the show
Social Security Affiliation

Exclusion criteria

Serious form Covid-19 risk factors
Positive saliva rapid test on the day of the event (and people who came with a positive person)
History of SARS-CoV-2
SARS-CoV-2 vaccination
Living with a person older than 75 years old or having a serious form of Covid-19 risk factor
Protection of a legal conservator
Pregnant or breastfeeding women
People living with a pregnant or breastfeeding woman