跳至主要内容
临床试验/NCT05892549
NCT05892549招募中不适用

COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 1,188 人开始时间: 2023年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,188
试验地点
1
主要终点
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening

研究概览

简要总结

In some clinical forms of COVID-19, an uncontrolled hyper-inflammatory reaction known as a "cytokine storm" appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (ICU).

At present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation.

The study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance.

Having a predictive respiratory pattern for worsening in COVID-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • French speaking
  • Affiliated to a social security system
  • Owning a mobile phone capable of accessing the COVOICE application

排除标准

  • Incapable adults
  • People deprived of their liberty
  • People under administrative or judicial supervision
  • Patients intubated or hospitalized in intensive care unit

结局指标

主要结局

Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening

时间窗: Through study completion (36 months)

Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening

时间窗: Through study completion (36 months)

次要结局

未报告次要终点

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (1)

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