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Transmission of Covid-19 During Clubbing Events in Closed Places

NCT05311865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1216

Last updated 2022-04-05

No results posted yet for this study

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

OTHER

Club event

Participate in a club event without a mask, indoors, with vaccinated people.

Sponsors & Collaborators

  • Cerballiance

    collaborator UNKNOWN

  • Kappa Santé

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Yazdan Yazdanpanah, Pr · ANRS, Emerging Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-04
Primary Completion
2021-10-17
Completion
2022-02-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05311865 on ClinicalTrials.gov