Transmission of Covid-19 During Clubbing Events in Closed Places (ITOC)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participant
• Intervention / Treatment: Other: Club event

• Study Type: Interventional
• Enrollment (Actual): 1216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • ANRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: participating to the event	Other: Club event; Participate in a club event without a mask, indoors, with vaccinated people.
No Intervention: Non partipating to the event

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of positive RT-PCR at day 7	Number of participants in each groups with a positive salivary RT-PCR	Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Kappa Santé; Cerballiance
• Investigators: Study Director: Yazdan Yazdanpanah, Pr, ANRS, Emerging Infectious Diseases

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2021
• Primary Completion (Actual): October 17, 2021
• Study Completion (Actual): February 26, 2022

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Transmission; SARS CoV-2; vaccinated; Night-club
• Other Study ID Numbers: ANRS0066s

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No