Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2021-06-13

Brief Summary

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The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.

The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.

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Detailed Description

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Before inclusion, the participants will be able to pre-register to the event via a website. They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).

During 3 days (from D-3 to D-1), participants with a registration will come to the Accor Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).

If the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases.

People with a negative test will be included and randomized :

* Two kits with tube for collecting saliva samples (for D0 and D7) will be given to each participant at this visit
* People randomized in the experimental group will receive their concert ticket at a later date.
* At Day 0, people randomized in the experimental group, will come to the Accor Arena with their ticket to participate in the concert. At the entrance, they should give their D0 saliva sampling kit. The people randomized in the control group will stay at home and will send their D0 saliva sample by post mail.
* At Day 7 (±1 day) all the participants must return their D7 saliva sampling kit via post mail

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental

People at the concert

Group Type EXPERIMENTAL

Concert

Intervention Type OTHER

People attending a concert in a closed area, with a mask

Rapid nasopharyngeal antigen test for Sars-Cov-2

Intervention Type DIAGNOSTIC_TEST

A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility

Saliva Sample

Intervention Type DIAGNOSTIC_TEST

Saliva samples sent by participant at Day0 and Day7

Control

People staying at home

Group Type ACTIVE_COMPARATOR

Rapid nasopharyngeal antigen test for Sars-Cov-2

Intervention Type DIAGNOSTIC_TEST

A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility

Saliva Sample

Intervention Type DIAGNOSTIC_TEST

Saliva samples sent by participant at Day0 and Day7

Interventions

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Concert

People attending a concert in a closed area, with a mask

Intervention Type OTHER

Rapid nasopharyngeal antigen test for Sars-Cov-2

A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility

Intervention Type DIAGNOSTIC_TEST

Saliva Sample

Saliva samples sent by participant at Day0 and Day7

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* aged between 18 and 45 years old
* lack of symptoms or no contact with people with Covid-19 in the last two weeks
* negative antigenic test to Covid-19 in the 3 days before the experiment
* people who declared to have no risk factor to severe form of Covid-19
* people who declared not to live in the same place as someone with these risk factors
* people residing in Ile-de-France area

Exclusion Criteria

* positive test to Sars-Cov-2 within 3 days before the concert
* people with clinical signs suggesting infectious respiratory disease
* people with severe Covid-19 risk factor
* people living with someone having severe covid-19 risk factor
* not affiliated to social security
* people who cannot remain standing for the time of the experimentation (about 5 hours)
* person under tutorship or curatorship
* pregnant women or not having effective contraception method
* breastfeeding women

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes