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

ANRS, Emerging Infectious Diseases

Status

Completed

Conditions

Healthy Participant

Treatments

Other: Club event

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05311865

ANRS0066s

Details and patient eligibility

About

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.

Enrollment

1,216 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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