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 Crepey (4, 5, 6, 7) , Ronan Garlantezec (8, 9) , Véronique Doré (10) , Audrey Dumas (10) , Mohamed Ben Mechlia (10) , Pierre Tattevin (9, 11) , Jean Gaudart (12) , Bruno Spire (13, 12) , France Lert (10) , Yazdan Yazdanpanah (10, 14) , Constance Delaugerre (15) , Marion Noret (16) , Jeremy Zeggagh (17)

1 LEPS - Laboratoire éducations et promotion de la santé
2 Service de maladies infectieuses et tropicales [CHU Avicenne]
3 CIC 1417 - CIC Cochin Pasteur
4 METIS - Département Méthodes quantitatives en santé publique
5 ARENES - Arènes: politique, santé publique, environnement, médias
6 RSMS - Recherche sur les services et le management en santé
7 EHESP - École des Hautes Études en Santé Publique [EHESP]
8 Irset - Institut de recherche en santé, environnement et travail
9 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
10 ANRS - Agence Nationale de Recherches sur le Sida et les Hépatites Virales
11 BRM - ARN régulateurs bactériens et médecine
12 SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
13 ISSPAM - Institut des sciences de la santé publique [Marseille]
14 Services de Maladies Infectieuses et Tropicales [CHU Bichat]
15 GenCellDis (U944 / UMR7212) - Génomes, biologie cellulaire et thérapeutiques
16 Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
17 AP-HP - Hopital Saint-Louis [AP-HP]

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.

Mots clés: SARS-CoV-2; respiratory virus; nightclub; respiratory virus transmission; vaccine; SARS-CoV-2

Domaines: Maladies infectieuses; Maladies émergentes; Santé publique et épidémiologie

Jeanne Goupil de Bouillé, Liem Binh Luong Nguyen, Pascal Crepey, Ronan Garlantezec, Véronique Doré, et al.. Transmission of SARS-CoV-2 during indoor clubbing events: A clustered randomized, controlled, multicentre trial protocol. Frontiers in Public Health, 2022, 10, pp.981213. ⟨10.3389/fpubh.2022.981213⟩. ⟨hal-03847496⟩