Clinical trial NCT05311865: Transmission of Covid-19 During Clubbing Events in Closed Places
Official title: Transmission of Covid-19 During Clubbing Events in Closed Places
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participant
Keywords: SARS CoV-2
Transmission
vaccinated
Night-club
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Cerballiance
name: Kappa Santé
First posted: 2022-04-05
Enrollment: 1216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of positive RT-PCR at day 7
timeFrame: Day 7
Secondary outcomes:
measure: Number of SARS-CoV-2 infection cases
timeFrame: Day 5 up to day 10
measure: Number of participants with seasonal respiratory viruses
timeFrame: Day 0 and day 7
measure: Number of symptomatic and asymptomatic respiratory infection
timeFrame: Day 5 to day 10
measure: Number of detected virus in the air
timeFrame: Day 0
measure: Number of mutations, deletions and insertions on the viral genome in participants samples
timeFrame: Day 0 and day 7
measure: Number of mutations, deletions and insertions on the viral genome in Aerosol samples
timeFrame: Day 0 and day 7
measure: Percentage of divergence between phylogenetic analysis of participants and aerosol samples
timeFrame: Day 0 and day 7
measure: Percentage of Health protocol adherence
timeFrame: Day 1
measure: Percentage of Interactions between the participants during the event
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: ANRS
Study officials:
affiliation: ANRS, Emerging Infectious Diseases
name: Yazdan Yazdanpanah, Pr
role: STUDY_DIRECTOR
References: