Clinical trial NCT04872075: Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
Official title: Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Sars-Cov-2
Covid-19
Screening
Concert
Closed area
Standing configuration
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: PRODISS
name: WEEZEVENT
First posted: 2021-05-04
Enrollment: 6678
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert
timeFrame: 7 days after the concert (-1/+8 days)
Secondary outcomes:
measure: Number of participants in each group with a positive salivary RT-PCR the day of the concert
timeFrame: The day of the concert
measure: Molecular analysis of transmission clusters
timeFrame: 7 days after the concert (-1/+8 days)
measure: Average percentage of participants wearing their mask adequately for the duration of event
timeFrame: The day of the concert
measure: Percentage of adequate mask wearing among participants according to location and time
timeFrame: The day of the concert
measure: Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion
timeFrame: The day of the concert
Other outcomes:
Locations:
city: Paris
country: France
facility: AccorHotels Arena
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Constance DELAUGERRE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delaugerre C, Foissac F, Abdoul H, Masson G, Choupeaux L, Dufour E, Gastli N, Delarue SM, Nere ML, Minier M, Gabassi A, Salmona M, Seguineau M, Schmitt S, Tonglet S, Olivier A, Poyart C, Le Goff J, Lescure X, Kerneis S, Treluyer JM; SPRING study group. Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2022 Mar;22(3):341-348. doi: 10.1016/S1473-3099(21)00673-3. Epub 2021 Nov 26.