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临床试验/NCT04326114
NCT04326114Unknown不适用

Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial

Universidad Complutense de Madrid0 个研究点目标入组 240 人开始时间: 2020年7月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
主要终点
COVID-19 disease diagnosis

研究概览

简要总结

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects

排除标准

  • Neurology diseases
  • Rheumatic diseases
  • Systemic diseases

结局指标

主要结局

COVID-19 disease diagnosis

时间窗: Change from Baseline COVID-19 disease diagnosis at 8 weeks

Dichotomous categorical variable measured by "yes" or "no" responses

次要结局

  • COVID-19 disease symptoms severity(Change from Baseline COVID-19 disease symptoms severity at 8 weeks)
  • Adverse effects(Change from Baseline adverse effects at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

César Calvo Lobo

Principal Investigator

Universidad Complutense de Madrid

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