Transmission of Covid-19 During Clubbing Events in Closed Places
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,216
- 试验地点
- 2
- 主要终点
- Number of positive RT-PCR at day 7
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Number of positive RT-PCR at day 7
时间窗: Day 7
Number of participants in each groups with a positive salivary RT-PCR
次要结局
- Number of mutations, deletions and insertions on the viral genome in participants samples(Day 0 and day 7)
- Number of SARS-CoV-2 infection cases(Day 5 up to day 10)
- Number of participants with seasonal respiratory viruses(Day 0 and day 7)
- Number of mutations, deletions and insertions on the viral genome in Aerosol samples(Day 0 and day 7)
- Number of symptomatic and asymptomatic respiratory infection(Day 5 to day 10)
- Percentage of Health protocol adherence(Day 1)
- Percentage of Interactions between the participants during the event(Day 1)
- Percentage of divergence between phylogenetic analysis of participants and aerosol samples(Day 0 and day 7)
- Number of detected virus in the air(Day 0)