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临床试验/NCT04381312
NCT04381312Unknown不适用

COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年4月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
mortality

研究概览

简要总结

This study propose to describe risk factors for acute and long term mortality of COVID 19 in patients up to 70 years old.

详细描述

In December 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020, by WHO. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients exhibits more complications (ARDS, delirium, cardiac and renal insufficiency) needing intensive care, and often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%).

Very few data are available the specific burden of Infectious diseases (ID) in older populations. The large majority of literature is often related to intrahospital or direct mortality and only recently arise the idea of indirect impact of ID particularly in that populations. In that meaning, ID may be considered as a trigger of other medical events such as myocardial infarction, stroke, or other specific outcomes such as functional decline; For the last 10 years, the Specific interest group " GInGer "( Groupe Infectio-Geriatrique ) a network of infectiologist and geriatrician SPILF/SFGG) carried out several studies on different aspects of ID in theses populations and recently demonstrated the indirect and long term impact of influenza and Clostridioides difficile infections. As an example, In influenza study, death-rate increases from 12,2 % in hospital related death to 25% at 3 months with high rate of complications (57%), high rates of rehospitalisation (25%) and functional decline (35%) leading to high increase in nursing home admission. The cost of these indirect impact is high and underestimated.

Because of incidence and comorbidities rates, severity of the actual French older COVID 19-infected older populations and because of the potential indirect and long term impact of COVID19 in these populations, it seems essential to know whether 3 month related death is largely higher as for influenza, to determine risk factors for intra hospital and long term death, measure acute and long term complications, and describe the impact of COVID 19 on specific ageing outcomes such as functional status at Month 3 (M3).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • + positive PCR confirmed COVID 19 (confirmed case) or positive Thoracic CT Scan - (probable case)

排除标准

  • Direct admission in Intensive care.

结局指标

主要结局

mortality

时间窗: 12 months

12 month survival curve

Risk factors for death

时间窗: 12 months

Specific COVID 19 risk factors for death and geriatric risk factors for death

次要结局

  • Admission in nursing home(3 months post acute phase)
  • Rehospitalisation(3 months post acute phase)
  • Describe clinical symptoms specific to old population(before and at admission)
  • describe specific and non-specific treatments used for COVID 19(through study completion, an average of 1 year)
  • describe all acute complications(through study completion, an average of 1 year)
  • functional decline(3 months post acute phase)
  • medical complications(3 months post acute phase)
  • risk factors for 3-month functional decline, acute complication and admission to nursing home(3 months post acute phase)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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