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| Name | Class |
|---|---|
| Cerballiance | UNKNOWN |
| Kappa Santé | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participating to the event | Experimental |
| |
| Non partipating to the event | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Club event | Other | Participate in a club event without a mask, indoors, with vaccinated people. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yazdan Yazdanpanah, Pr | ANRS, Emerging Infectious Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ANRS | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37795682 | Derived | Luong Nguyen LB, Goupil de Bouille J, Menant L, Noret M, Dumas A, Salmona M, Le Goff J, Delaugerre C, Crepey P, Zeggagh J; ITOC Study Group. A Randomized Controlled Trial to Study the Transmission of SARS-CoV-2 and Other Respiratory Viruses During Indoor Clubbing Events (ANRS0066s ITOC Study). Clin Infect Dis. 2023 Dec 15;77(12):1648-1655. doi: 10.1093/cid/ciad603. | |
| 36438274 |
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Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.
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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 |
| Goupil de Bouille J, Luong Nguyen LB, Crepey P, Garlantezec R, Dore V, Dumas A, Ben Mechlia M, Tattevin P, Gaudart J, Spire B, Lert F, Yazdanpanah Y, Delaugerre C, Noret M, Zeggagh J. Transmission of SARS-CoV-2 during indoor clubbing events: A clustered randomized, controlled, multicentre trial protocol. Front Public Health. 2022 Nov 4;10:981213. doi: 10.3389/fpubh.2022.981213. eCollection 2022. |