The Protective Effect of Mask Wearing Against Respiratory Tract Infections: a Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,575
- 试验地点
- 2
- 主要终点
- Respiratory symptoms of the common cold, influenza or COVID-19
研究概览
简要总结
In this trial the researchers plan to recruit 4,000 volunteers to be randomly allocated either wearing face masks in public spaces where they are close to other people, or not wear face masks in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about whether they experienced the common cold, influenzas or COVID-19 symptoms during the trail period.
详细描述
This study is a pragmatic, two-armed cluster randomized superiority trial including participants in Norway. Participants will be randomized to one of the following two arms: control group or medical masks in a 1:1 ratio. The primary outcome is self-reported respiratory infection.
The intervention is to ask participants in the intervention groups to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. The control group will be asked not to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. Participants will continue to use, or not use, face masks at work independent of which group they are allocated to.
The trial will be fully remote and without any personal interaction between investigators and participants.
The researchers aim to include about 4,000 participants to have a statistical power of 80% to detect a relative risk reduction of 30% for the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 18 years of age
- •Are willing to be randomized to wear, or not to wear, face masks outside their home when close to others for a 14-day period
- •Provide informed consent
排除标准
- 未提供
结局指标
主要结局
Respiratory symptoms of the common cold, influenza or COVID-19
时间窗: Day 1 to 17
Self-report
次要结局
- Positive test for SARS-CoV-2(Day 3 to 17 after start of tiral period)
- Covid-19 prevalence(Day 1 to 17)
- Health care use for injuries(Day 1 to 17)
- Health care use for respiratory symptoms(Day 1 to 17)
- Health care use (all causes)(Day 1 to 17)