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临床试验/NCT05069389
NCT05069389进行中(未招募)不适用

Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments

Centre Hospitalier Emile Roux1 个研究点 分布在 1 个国家目标入组 2,071 人开始时间: 2020年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,071
试验地点
1
主要终点
Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments.

研究概览

简要总结

The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19

详细描述

Coronavirus infection (SARS-Cov2), very contagious, is benign in the most cases but can be complicated by an acute respiratory distress syndrome, for which an invasive mechanical ventilation in resuscitation is necessary with an important mortality rate. This infection is about an important health crisis with a fast saturation of the health system.

In front of the novelty of this virus, any effective treatment has been demonstrated in humans and researches have accelerated as this pandemic continues.

First available results, in chinese population, have not demonstrated superiority of the Lopinavir/Ritonavir association versus standard care (Cao et al. 2020). In a randomized study in 62 chinese patients, Chen et al. seems to find a clinical efficacy of the Hydroxychloroquine compared to placebo. Gautret et al. has also found a decreased viral load in nasopharyngeal swabs in patients affected by COVID-19, treated by Hydroxychloroquine and by the association of Hydroxychloroquine-Azythromycine. However, these preliminary results doesn't allow to conclue on the efficacy against COVID-19.

Currently, any treatment in particular is recommanded for patients affected by COVID-19. Randomized studies on a larger scale and greater rigor at national and european level are in process to determine the efficacy of several treatments.

Pending results of these studies, healthcare establishments had to adapt and strategize to take care their patients. These strategies have rapidely evolved during this pandemy, in terms of the therapeutic clinical studies opening, the acquisition of new knowledges on COVID-19, and treatments.

研究设计

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

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

  • Any adult patient admitted to the establishment for treatment for a SARS-Cov2 infection
  • Positive RT-PCR or a scanner suggestive of COVID-19 during the stay, or with a positive serology (even if carried out after the patient's discharge)
  • Hospitalization > 24h
  • Patients receiving any type of care, whether it is recommended standard care or off-label treatment as part of a therapeutic clinical trial or outside the scope of clinical research

排除标准

  • Opposition to the use of data following written patient information
  • Patient transferred from another hospital to continue COVID care and whose initial care data is not available

结局指标

主要结局

Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments.

时间窗: During the hospitalization

The use of specific treatments or specific care in COVID unit, inclusion in clinical trials, will be combined to report the evolution of French recommendations and scientific literature around the COVID-19.

次要结局

  • Evaluate the effectiveness of the care(During the hospitalization)
  • Describe management strategies to take care depending on the patient(During the hospitalization)
  • Compare patients' clinical course who received different management strategies(During the hospitalization)
  • Evaluate the cost of the care(During the hospitalization)

研究者

发起方
Centre Hospitalier Emile Roux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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