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. 2022 Nov 4:10:981213.
doi: 10.3389/fpubh.2022.981213. eCollection 2022.

Transmission of SARS-CoV-2 during indoor clubbing events: A clustered randomized, controlled, multicentre trial protocol

Jeanne Goupil de Bouillé  1   2 , Liem Binh Luong Nguyen  3 , Pascal Crépey  4 , Ronan Garlantezec  5 , Véronique Doré  6 , Audrey Dumas  6 , Mohamed Ben Mechlia  6 , Pierre Tattevin  7 , Jean Gaudart  8 , Bruno Spire  9 , France Lert  6 , Yazdan Yazdanpanah  6   10 , Constance Delaugerre  11 , Marion Noret  12 , Jeremy Zeggagh  13
Affiliations

Transmission of SARS-CoV-2 during indoor clubbing events: A clustered randomized, controlled, multicentre trial protocol

Jeanne Goupil de Bouillé et al. Front Public Health. .

Abstract

Introduction: The SARS-CoV-2 pandemic led to the implementation of several non-pharmaceutical interventions (NPIs), from closings of bars and restaurants to curfews and lockdowns. Vaccination campaigns started hoping it could efficiently alleviate NPI. The primary objective of the "Indoor Transmission of COVID-19" (ITOC) study is to determine among a fully vaccinated population the relative risk of SARS-CoV-2 transmission during one indoor clubbing event. Secondary objectives are to assess the transmission of other respiratory viruses, risk exposure, and attitudes toward COVID-19 vaccination, health pass, and psychological impact of indoor club closing.

Methods and analysis: Four thousand four hundred healthy volunteers aged 18-49 years and fully vaccinated will be included in Paris region. The intervention is an 8-hour indoor clubbing event with no masks, no social distance, maximum room capacity, and ventilation. A reservation group of up to 10 people will recruit participants, who will be randomized 1:1 to either the experimental group (2,200 volunteers in two venues with capacities of 1,000 people each) or the control group (2,200 volunteers asked not to go to the club). All participants will provide a salivary sample on the day of the experiment and 7 days later. They also will answer several questionnaires. Virological analyses include polymerase chain reaction (PCR) of salivary samples and air of the venue, investigating SARS-CoV-2 and 18 respiratory viruses.

Ethics and dissemination: Ethical clearance was first obtained in France from the institutional review board (Comité de Protection des Personnes Ile de France VII - CPP), and the trial received clearance from the French National Agency for Medicines and Health Products (Agence National de Sécurité du Médicament - ANSM). The trial is supported and approved by The Agence Nationale Recherche sur le SIDA, les hépatites et maladies émergences (ANRS-MIE). Positive, negative, and inconclusive results will be published in peer-reviewed scientific journals.

Trial registration number: IDR-CB 2021-A01473-38. Clinicaltrial.gov, identifier: NCT05311865.

Keywords: SARS-CoV-2; nightclub; respiratory virus; respiratory virus transmission; vaccine.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Plan of the room “La Machine du moulin rouge” and location of the AerosolSense™ and ventilation.
Figure 2
Figure 2
Plan of the room “La Bellevilloise” and locations of the AerosolSense™ and ventilation.
Figure 3
Figure 3
Minimal detectable relative risk depending on the number of subjects in the intervention group for different levels of incidence of SARS-CoV-2 infection detected in the general population. With 2,000 subjects in each arm (intervention and control), we have a power of 80% to detect a relative risk of 3–4.4 depending on the level of SARS-CoV-2 incidence.
See this image and copyright information in PMC

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