Healthy Participant
Conditions
Keywords
SARS CoV-2, Transmission, vaccinated, Night-club
Brief summary
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.
Interventions
OTHERClub event
Participate in a club event without a mask, indoors, with vaccinated people.
Sponsors
Cerballiance
Kappa Santé
ANRS, Emerging Infectious Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of positive RT-PCR at day 7 | Day 7 | Number of participants in each groups with a positive salivary RT-PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of SARS-CoV-2 infection cases | Day 5 up to day 10 | Numbers of asymptomatic, symptomatic, and severe SARS-CoV-2 infection according to a self-assessment by a questionnaire sent online in each group |
| Number of participants with seasonal respiratory viruses | Day 0 and day 7 | Number of participants in each group with a positive seasonal respiratory viruses PCR |
| Number of symptomatic and asymptomatic respiratory infection | Day 5 to day 10 | Numbers of asymptomatic, symptomatic, and severe seasonal respiratory viruses infection according to a self-assessment by a questionnaire sent online |
| Number of mutations, deletions and insertions on the viral genome in participants samples | Day 0 and day 7 | Whole genome sequencing of virus detected in participants samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences |
| Number of detected virus in the air | Day 0 | Number of detected virus in the air, by the AerosolSense |
| Percentage of divergence between phylogenetic analysis of participants and aerosol samples | Day 0 and day 7 | Establishing the distance matrix between the viruses in participants samples and viruses detected by aerosol sense |
| Percentage of Health protocol adherence | Day 1 | 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. |
| Percentage of Interactions between the participants during the event | Day 1 | Percentage of responses to a questionnaire assessing number of individual interactions during the event |
| Number of mutations, deletions and insertions on the viral genome in Aerosol samples | Day 0 and day 7 | Whole genome sequencing of virus detected in Aerosol samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences |
Countries
France
Outcome results
None listed