7500 participants
Divided into 2 groups:
“Experimental” group
5,000 people at the concert
“Control” group
2,500 people at home
The detailed study
The context
Since February 2020, the COVID-19 epidemic has shut down all cultural venues and gatherings (including large gatherings that have never resumed) and to prevent any outbreaks. Since then, entertainment professionals have been waiting for health protocols to allow them to relaunch their activities.
The Ambition Live Again project was born from this observation and from the desire of health and entertainment professionals to unite and take action to help the cultural sector recover.
The principle of the study
This study, called SPRING*, on which the Ambition Live Again project is based, hypothesizes that systematic screening for SARS-CoV-2 within 3 days maximum before the event makes it possible to control the risk of transmission and generation of epidemic foci during the concert and access to it.
This upstream screening makes it possible to assess the overexposure to the risk of a full-scale concert, ie 5,000 people standing, not distanced in the pit of the Accor Arena in Paris Bercy. With the eviction of confirmed positive cases and symptomatic people on the day of the concert, it is expected that the number of people infected during the concert will be equivalent to the number of people infected among the “control” group (those who will not attend the concert. concert).
*SPRING: Study on PRevention of SARS-CoV-2 transmission in a large INdoor Gathering event (name of scientific study sponsored by AP-HP).
The organization and the health protocol put in place in this study are linked to research constraints, they are not intended to become a standard or a model for the reopening of places of culture. The objective of this clinical trial is to obtain measurements allowing to build the conditions for the resumption of live.
The sanitary protocol
In order to ensure the safety of participants in this experiment, a strict health protocol is in place:
Wearing a surgical mask
(given at the entrance)
Provision of hydroalcoholic solution
Negative test carried out at most 3 days before
No bars or restaurants
Optimized ventilation of the venue
Test of production teams & artists
The selection of participants
Participation in this study is conditional on inclusion and non-inclusion criteria defined by the AP-HP clinical research unit.
It is possible to register for a draw to participate in the study, using an online form (Paris region only).
Inclusion criteria
- Adults and between 18 and 45 years old
- No symptoms or contact with people with COVID-19 for 2 weeks
- Antigenic screening test negative within 3 days before the experiment
- People who declared that they were not carriers of any serious risk factor (HCSP criteria of 29/10/2020)
- People who said they do not live under the same roof as a person with these factors
- Residing in Ile-de-France (Paris region)
Non-inclusion criteria
- Positive antigenic screening test within 3 days before the experiment
- People with clinical signs suggestive of infectious respiratory disease
- People with a severe COVID-19 risk factor
- People living with someone with risk factors for severe COVID-19
- Persons not affiliated to social security
- People who cannot stand standing for the duration of the experiment (about 5 hours)
- People under tutorship or curatorship
- Women who are pregnant or do not have effective contraception, by oral declaration
- Breastfeeding women
The participant journey
From 12/05
Registration to participate in the study
Individual approach & according to the inclusion criteria.
From 17/05
Random draws for 7,500 participants
Selected among the pre-registered, in several phases.
From 17/05
Making an appointment for a screening test
Made at the Accor Arena.
25/05 to 28/05
Test within 3 days before the concert
Must be negative to participate in the study.
25/05 to 28/05
Randomization
Random distribution in 2 groups: 5000 participants in the concert ("experimental" group) / 2500 participants at home ("control" group).
29/05
5,000 people at the concert at the Accor Arena
Deposit of the salivary self-test at the entrance on the day of the concert.
29/05
2,500 people at home
Return by post of the salivary self-test the day of the concert.
5/06
Salivary self-test sent by post
7 days after the concert.
The ancillary studies
Control of test evidence (TousAntiCovid or certificate)
In order to facilitate the reopening of places open to the public, new features of the TousAntiCovid application have been developed by the Ministries of Solidarity and Health, and of Digital. These lay the foundations for the health pass promoted by the government and currently under discussion in Parliament.
The TousAntiCovid application now includes a test and vaccination booklet. Once the results of the screening tests have been obtained, the positive or negative result must be transmitted to the national SI-DEP database by laboratories (RT-PCR tests) or by health professionals performing antigenic tests. A certified datamatrix QR-code (2D-DOC standard) containing in particular: last name / first name / date of the test / type of test and test result is automatically generated when a COVID-19 test is reported in the SI-DEP database . A secure link is then sent to the patient by SMS to allow him to retrieve his test certificate and insert it into his TousAntiCovid application or to print the paper version containing this test proof.
As part of the Ambition Live Again project, this new functionality will be tested in real conditions for the first time on an event. Participants will be encouraged to download the TousAntiCovid application upon inclusion in the study. Once the antigen test has been performed at the Accor Arena, the result transmitted to SI-DEP can be integrated into the application via the certified test proof, or printed on paper.
At the entrance of this experimental concert, the test proof (QR-code datamatrix) present in the TousAntiCovid application or its paper form, will be scanned to certify the non-positivity of the participants.
Mask wearing analysis (statistics via camera detection)
Wearing a mask is now recognized as one of the major axes in the prevention of the transmission of SARS-CoV-2, including in community settings. However, the support of the population for this measure, and especially the ability of the general public to wear a mask adequately (i.e. covering the nose and mouth) in a festive context, have rarely been evaluated.
To measure the wearing of the mask on a crowd of 5,000 people, the use of artificial intelligence (AI) is necessary. The Datakalab company has developed a technological solution for detecting the wearing of a mask based on the analysis of images captured by video, while protecting personal data through real-time anonymization. The treatments that are applied to the videos follow a conventional treatment chain in facial analysis. First, a face detector can identify all of the faces present in each frame of the video. The rough position of these faces is then refined using a detector of characteristic points of the face (corners of the mouths, eyes, outline, etc.) to refine and normalize the position of each of the faces. Secondly, each face thus “cut out” is processed by an AI model trained to decide whether a mask is present on this face (this model was previously trained from annotated face data). It is thus possible to determine for each image of the video the proportion of people wearing a mask. These treatments do not involve any biometric processing at any time since the objective is to detect faces and the wearing of a mask regardless of the person’s identity.
This technology is currently used on the Ile-de-France public transport network, in collaboration with the RATP, to guide specific user awareness measures. Since the technology makes it possible to produce statistics of compliance with mask wearing according to the time of day, it is thus possible, for example, to strengthen the dissemination of awareness messages at times when mask wear decreases.
This is the first time that this technology will be used in a concert hall. Despite the different light conditions, the first scouting made it possible to validate that the data could be used before / after and in the corridors leading to the main room.
Cameras will be placed in different places in the enclosure of the experiment (concert hall, access doors, passageways) and the data will be recorded continuously throughout the duration of the event, from the entrance to the exit of the spectators. This will help identify the circumstances and how to wear the mask, depending on the location and time of the event.
The SPRING* study in figures, is:
*Study on PRevention of SARS-CoV-2 transmission in a large INdoor Gathering event (name of the scientific study promoted by AP-HP).
7500 participants
3 screening tests
D-3
Antigenic nasopharyngeal test, made at the Accor Arena
D-Day
PCR saliva test, by self-sampling
D+7 :
PCR saliva test, by self-sampling
2 ancillary studies
Control of test evidence
(TousAntiCovid or certificate)
Mask wearing analysis
Camera detection
The research team
Coordinator Investigator
Pr Constance Delaugerre
Hôpital Saint Louis, AP-HP
Scientific Leaders
Dr Solen Kernéis
Hôpital Bichat, AP-HP
Pr Xavier Lescure
Hôpital Bichat, AP-HP
Necker Cochin Clinical Research Unit
Pr Jean-Marc Tréluyer
Coordinator
Dr Hendy Abdoul
Assistant coordinator
Frantz Foissac
Methodologist
Naim Bouazza
Methodologist
Eric Dufour
Project manager
Laure Choupeaux
Project manager
Guillaume Masson
Project manager
Promoter
Assistance Publique Hôpitaux de Paris (AP-HP)
Delegation for Clinical Research and Innovation (DRCI)
Shohreh AZIMI
Project manager
