Status:
COMPLETED
Transmission of Covid-19 During Clubbing Events in Closed Places
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Cerballiance
Kappa Santé
Conditions:
Healthy Participant
Eligibility:
All Genders
18-49 years
Phase:
NA
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 maximu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2022
Estimated Enrollment :
1216 Patients enrolled
Trial Details
Trial ID
NCT05311865
Start Date
September 4 2021
End Date
February 26 2022
Last Update
April 5 2022
Active Locations (1)
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1
ANRS
Paris, France, 75013