Transmission of Covid-19 During Clubbing Events in Closed Places

Study Overview
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Brief Summary
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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.

Official Title
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Transmission of Covid-19 During Clubbing Events in Closed Places

Conditions
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Healthy Participant

Intervention / Treatment
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* Other: Club event


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 49 years old Vaccination completed People who declared to have no risk factor to severe form for Covid-19 disease People who declared not to live in the same place as someone with these risk factors People residing in Ile-de-France area People affiliated with the the French social security citizen scheme Exclusion criteria: Presence of symptoms of COVID in the 2 weeks before the event Pregnant woman or woman who declares not having an effective contraception method Self identification of medical conditions or comorbidities identified as a proven risk of severe COVID infection People living with a person with these risk factors Confirmed diagnosis of SARS-CoV-2 within two weeks before the event Participants under tutorship or curatorship; Underage participants; Participants unable to give free and informed consent; Participants not affiliated to the French social security citizen scheme: obligation to join a social security scheme or be a beneficiary thereof. Participants under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participating to the event<br> | Other: Club event<br>* Participate in a club event without a mask, indoors, with vaccinated people.<br>|
| No Intervention: Non partipating to the event<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive RT-PCR at day 7 | Number of participants in each groups with a positive salivary RT-PCR | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Day 5 to day 10 | 
| Number of detected virus in the air | Number of detected virus in the air, by the AerosolSense | 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 | 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 | 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 | 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. | 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 | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS CoV-2, Transmission, vaccinated, Night-club