NCT06885229撤回2 期
Reuseable Face Masks to Reduce Risk of Viral Respiratory Infections and Exacerbations in Adults With Asthma: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Time to first RT-PCR-proven viral respiratory infection
研究概览
简要总结
REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections and asthma exacerbations.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility criteria, participants with asthma ('index participants'):
- •Inclusion Criteria:
- •Aged 16 or more years
- •Doctor diagnosis of asthma
- •Current prescription for treatment of asthma
- •Participant in COVIDENCE UK nasal swab study
排除标准
- •Regularly using any FFP-rated face mask when in an indoor public place
- •Currently sharing household with one or more children
- •Currently sharing household with one or more other COVIDENCE UK participants who have asthma
- •Unable to tolerate wearing face mask
- •Eligibility criteria, household members of index participants:
- •Inclusion criteria
- •Age 16 or more
- •Living in same household as index participant who has consented to take part in trial
- •Exclusion criteria
- •Unable to tolerate wearing face mask
结局指标
主要结局
Time to first RT-PCR-proven viral respiratory infection
时间窗: 12 months
次要结局
- Time to first severe acute exacerbation of asthma (i.e. exacerbation requiring treatment with systemic corticosteroids and/or hospitalisation or emergency department visit)(12 months)
- Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation(12 months)
- Time to first antibiotic prescription for treatment of acute respiratory infection(12 months)
- Rate of RT-PCR-proven / symptom defined acute respiratory infections(12 months)
- Cost per viral respiratory infection averted(12 months)
- Cost per severe asthma exacerbation averted(12 months)
研究者
研究点 (1)
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