Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level.
In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone.
Follow-up will be implemented through telephone calls and post-epidemic home visits.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Household resident
- •Age: 10 years and older
排除标准
- •Refusal to participate
结局指标
主要结局
Mortality
时间窗: Four months follow-up
Any death during the follow-up period
Reported COVID-like illness
时间窗: Four months follow-up
Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
Consultation
时间窗: Four months follow-up
Consultation for COVID-19 like illness or/and reported positive test
Severe illness
时间窗: Four months follow-up
Self reported COVID-19 like illness plus hospitalization or death
次要结局
未报告次要终点
