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临床试验/NCT04471766
NCT04471766Unknown不适用

Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial

Bandim Health Project1 个研究点 分布在 1 个国家目标入组 40,000 人开始时间: 2020年7月20日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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