Transmission of Covid-19 During Clubbing Events in Closed Places

Not Applicable

Completed

• Conditions: Healthy Participant
• Interventions: Other: Club event

• Registration Number: NCT05311865
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-04
• Primary Completion: 2021-10-17
• Study Completion: 2022-02-26
• Study First Submitted: 2022-03-08
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-01
• Study First Posted: 2022-04-05
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1216

Inclusion Criteria

• Aged between 18 and 49 years old
• Vaccination completed
• People who declared to have no risk factor to severe form for Covid-19 disease
• People who declared not to live in the same place as someone with these risk factors
• People residing in Ile-de-France area
• People affiliated with the the French social security citizen scheme

Exclusion criteria:

• Presence of symptoms of COVID in the 2 weeks before the event
• Pregnant woman or woman who declares not having an effective contraception method
• Self identification of medical conditions or comorbidities identified as a proven risk of severe COVID infection
• People living with a person with these risk factors
• Confirmed diagnosis of SARS-CoV-2 within two weeks before the event
• Participants under tutorship or curatorship;
• Underage participants;
• Participants unable to give free and informed consent;
• Participants not affiliated to the French social security citizen scheme: obligation to join a social security scheme or be a beneficiary thereof.
• Participants under legal protection

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
participating to the event	Club event	-

Primary Outcome Measures

Name	Time	Method
Number of positive RT-PCR at day 7	Day 7	Number of participants in each groups with a positive salivary RT-PCR

Secondary Outcome Measures

Name	Time	Method
Number of mutations, deletions and insertions on the viral genome in participants samples	Day 0 and day 7	Whole genome sequencing of virus detected in participants samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences
Number of SARS-CoV-2 infection cases	Day 5 up to day 10	Numbers of asymptomatic, symptomatic, and severe SARS-CoV-2 infection according to a self-assessment by a questionnaire sent online in each group
Number of participants with seasonal respiratory viruses	Day 0 and day 7	Number of participants in each group with a positive seasonal respiratory viruses PCR
Number of mutations, deletions and insertions on the viral genome in Aerosol samples	Day 0 and day 7	Whole genome sequencing of virus detected in Aerosol samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences
Number of symptomatic and asymptomatic respiratory infection	Day 5 to day 10	Numbers of asymptomatic, symptomatic, and severe seasonal respiratory viruses infection according to a self-assessment by a questionnaire sent online
Percentage of Health protocol adherence	Day 1	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.
Percentage of Interactions between the participants during the event	Day 1	Percentage of responses to a questionnaire assessing number of individual interactions during the event
Number of detected virus in the air	Day 0	Number of detected virus in the air, by the AerosolSense
Percentage of divergence between phylogenetic analysis of participants and aerosol samples	Day 0 and day 7	Establishing the distance matrix between the viruses in participants samples and viruses detected by aerosol sense

Trial Locations

Locations (1)

ANRS; 🇫🇷 Paris, France