NCT05311865

Transmission of Covid-19 During Clubbing Events in Closed Places

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,216 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participant

Interventions

Type	Name	Description
OTHER	Club event	Participate in a club event without a mask, indoors, with vaccinated people.

Timeline

• Start date: 2021-09-04
• Primary completion: 2021-10-17
• Completion: 2022-02-26
• First posted: 2022-04-05
• Last updated: 2022-04-05

Locations

1 site across 1 country: France