Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- SARS-CoV-2 incidence
研究概览
简要总结
The investigators want to compare the SARS-CoV-2 incidence 7 days after having been screened negative, between two groups of adults randomized to either go to a concert or not.
Participants will be screened via a rapid saliva test a few hours before the show. The hypothesis is that attending a standing concert in respect of safety precaution doesn't increase the risk of SARS-CoV-2 infection.
详细描述
Context :
A previous Spanish randomized study in November 2020 concluded in a non superiority of the SARS-CoV-2 incidence in RT-PCR-negative participant of a concert compared to a control group. In the same way, investigators want to compare the SARS-CoV-2 incidence of participants of a concert 7 days after the show with a control group, using a saliva test.
While naso-pharyngeal RT-CPR is the gold-standard for virological SARS-COV-2 tests, this method can be painful and results take time. Saliva rapid tests have satisfactory diagnostic performances and easy access to results. Saliva rapid tests may lead to mass screening in cultural mass events.
This project has the specific feature to be set in closed concert hall with limited size attendance.
Methodology :
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 and less than 60 years old
- •Having completed the internet pre selection questionnaire and signed the consent form
- •Negative rapid saliva RT-LAMP EasyCov test on the day of the show
- •Social Security Affiliation
排除标准
- •Serious form Covid-19 risk factors
- •Positive saliva rapid test on the day of the event (and people who came with a positive person)
- •History of SARS-CoV-2
- •SARS-CoV-2 vaccination
- •Living with a person older than 75 years old or having a serious form of Covid-19 risk factor
- •Protection of a legal conservator
- •Pregnant or breastfeeding women
- •People living with a pregnant or breastfeeding woman
研究组 & 干预措施
Concert
Participants will go to a concert in a closed hall.
干预措施: Concert (Other)
Control
Participant will stay at home.
结局指标
主要结局
SARS-CoV-2 incidence
时间窗: 7 days after the first screening
Rate of newly SARS-CoV-2 infected participants
次要结局
- Time to screen all participants(At screening day)