Clinical trial NCT04896970: Risk of SARS-CoV-2 Infection (COVID-19) in a Standing Concert in a Closed Performance Hall
Official title: Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: SARS-CoV-2
Keywords: SARS-CoV-2
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 doesn't 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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 incidence
timeFrame: 7 days after the first screening
Secondary outcomes:
measure: Time to screen all participants
timeFrame: At screening day
Other outcomes:
Locations:
Study officials:
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