The ITOC study is a cluster randomised, controlled, multicentre trial in Paris region, France. The intervention is an 8-hour indoor clubbing event with no mask wearing, no social distancing, at maximum room capacity. 1,200 healthy volunteers aged 18-49 years and fully vaccinated will be included. Participants are recruited by group of up to 10, to be randomized 2:1 to experimental group (800 volunteers in a venue ) or control group (400 volunteers asked to stay at home). All participants will provide a salivary sample the day of experiment and seven days later. Participants will also answer surveys on the social and psychological impact of lockdown and indoor club closing, attitude towards vaccination, behaviour at risk of COVID-19 transmission during the day of the event (for both groups) as well as follow-up surveys on symptoms that participant may experience. Virological analyses include polymerase chain reaction (PCR) of salivary samples and air of the venue, investigating SARS-CoV-2 PCR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,216
Participate in a club event without a mask, indoors, with vaccinated people.
ANRS
Paris, France
Number of positive RT-PCR at day 7
Number of participants in each groups with a positive salivary RT-PCR
Time frame: Day 7
Number of SARS-CoV-2 infection cases
Numbers of asymptomatic, symptomatic, and severe SARS-CoV-2 infection according to a self-assessment by a questionnaire sent online in each group
Time frame: Day 5 up to day 10
Number of participants with seasonal respiratory viruses
Number of participants in each group with a positive seasonal respiratory viruses PCR
Time frame: Day 0 and day 7
Number of symptomatic and asymptomatic respiratory infection
Numbers of asymptomatic, symptomatic, and severe seasonal respiratory viruses infection according to a self-assessment by a questionnaire sent online
Time frame: Day 5 to day 10
Number of detected virus in the air
Number of detected virus in the air, by the AerosolSense
Time frame: Day 0
Number of mutations, deletions and insertions on the viral genome in participants samples
Whole genome sequencing of virus detected in participants samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences
Time frame: Day 0 and day 7
Number of mutations, deletions and insertions on the viral genome in Aerosol samples
Whole genome sequencing of virus detected in Aerosol samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences
Time frame: Day 0 and day 7
Percentage of divergence between phylogenetic analysis of participants and aerosol samples
Establishing the distance matrix between the viruses in participants samples and viruses detected by aerosol sense
Time frame: Day 0 and day 7
Percentage of Health protocol adherence
Percentage of positive responses to a questionnaire assessing degree of adherence to the health protocol by questionnaire sent online to participants and organizers after the evenings.
Time frame: Day 1
Percentage of Interactions between the participants during the event
Percentage of responses to a questionnaire assessing number of individual interactions during the event
Time frame: Day 1
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