Protective Measures Against SARS-CoV-2 Contamination of Healthy Voluntary Young Students During a Concert of Actual Music
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- SARS-CoV-2 conversion rates
研究概览
简要总结
The aim of this study is to assess whether the protective measures can limit the contaminations by SARS-CoV-2 during the participation in a concert at a non-inferior level to a non-concert / current life situation. A randomized, monocentric, open-label, non-inferiority study comparing, in two phases, a group of volunteers participating in a concert, protected by established protection measures, to a group with no other constraints than national recommendations and obligations (2 concerts, one control group at each concert). Volunteer students, between 18 and 30 years old, at Aix-Marseille University, will be recruited.
详细描述
Objectives
Primary objective To assess whether the protective measures implemented (individual protection kit including disposable FFP2 (filtering facepiece) masks, hydro-alcoholic solution, water bottle, disposable tissues, waste bag, physical distancing, flow management and health mediation) make it possible to limit contamination by SARS-CoV-2 during participation in a concert (lasting 2 hours) at a non-inferior level to a non-concert situation
Secondary objectives
- To assess whether the protective measures implemented (individual protection kit including disposable FFP2 masks, hydro-alcoholic solution, water bottle, disposable tissues, waste bag, physical distancing, flow management and health mediation) make it possible to limit contamination by other circulating respiratory viruses during participation in a concert (lasting 2 hours) at a non-inferior level to a non-concert situation
- To assess whether the protection against viral contamination in the absence of a one-seat gap between 2 volunteers is non-inferior to the protection induced by one-seat gap (sub-group of volunteers)
- To assess knowledge, attitudes and practices regarding COVID-19
- To assess the level of compliance and adherence to the prevention measures implemented during the concert
- To assess SARS-CoV-2 serology prevalence in volunteers
- To identify SARS-CoV-2 variants by sequencing SARS-CoV-2 PCR positive cases
Methodology / design A randomized, monocentric, open-label, non-inferiority study comparing, in two phases, a group of volunteers participating in a concert, protected by established protection measures (protection kit, distancing, flow management, health mediation), to a group with no other constraints than national recommendations and obligations (2 concerts, one control group at each concert).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Student at Aix Marseille University
- •who has declared that he or she does not carry any risk factor for severe forms of the disease (HCSP criteria of 29/10/2020)
- •who has declared that he or she does not live under the same roof as a person who does carry such factors, and committed to strictly following the study's health protocol,
- •carrying a smartphone which is registered on the "TousAntiCovid" application (with Bluetooth activation), and agreeing to install the Maela application on the smartphone for remote medical monitoring.
排除标准
- •Volunteer with clinical signs of acute respiratory infectious disease
- •Volunteer living with a person with clinical signs of acute respiratory infectious disease
- •Volunteer with a risk factor for severe COVID-19
- •Volunteer who had a COVID-19 infection in the 3 months prior to the study
- •Volunteer who are not affiliated to the social security system
- •Volunteer vaccinated against COVID-19
- •Pregnant women and people living with pregnant women
- •Persons deprived of liberty
- •Adult with legal protection
- •Volunteer unable to comply with protective measures, at the concert or at home
- •Volunteer participating in another clinical research study
结局指标
主要结局
SARS-CoV-2 conversion rates
时间窗: 6 to 7 days after attending to the musical event
PCR on saliva sample
次要结局
- Respiratory virus conversion rates(6 to 7 days after attending the concert)
- Types and importance of barriers to prevention measures(1 to 2 day before attending the concert)
- Types and importance of levers for adherence to prevention measures(1 to 2 days after attending the concert)
- Seroprevalence of SARS-CoV-2 in volunteers(1 to 2 days before attending the concert)
- SARS-CoV-2 variants among participant positive cases(6 to 7 days after attending the concert)