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临床试验/NCT04402905
NCT04402905已完成不适用

Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.

Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
试验地点
1
主要终点
COVID-PSL Cohort

研究概览

简要总结

COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.

If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).

However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.

Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.

Given the novelty of this infection, several questions remain:

  • What are all the symptoms that can be contracted by a COVID-19 patient?
  • Are there clinical forms not described?
  • What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?
  • What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?

详细描述

Most of the descriptive studies relating to COVID-19 relate to the severe forms of the disease managed in the hospital sector.

Few data have been published on moderate forms, requiring no hospitalization, of strict outpatient management.

These so-called moderate forms, however, constitute the majority of cases of COVID-19 (approximately 80%).

In the Infectious and Tropical Diseases Department of Pitie Salpetriere, COVIDOM pilot site, at the beginning of March, during the intensification of the epidemic in France, a weekly telephone consultation was set up to take care of people tested for COVID + by PCR, or people not tested by PCR, or even tested with negative PCR but symptomatic and followed at home, suffering from moderate form of COVID-19, as well as their contact cases if they wished.

Telemedicine is particularly suitable in this epidemic context, ensuring continuity of care, while limiting face-to-face consultations, thus reducing the risk of cross-contamination.

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

  • Age >18 years
  • COVID PCR + patient: Patient screened positive by PCR on nasopharyngeal swab
  • or COVID-like patient: Patient not screened, but considered COVID + because contact with a COVID PCR + person, and presenting symptoms suggestive of COVID-19 among:
  • Influenza-like illness (fever, body aches, arthralgia, etc.)
  • Respiratory form: dyspnea, cough, rhinitis
  • Gastrointestinal form: diarrhea, nausea, vomiting
  • Anosmia and / or ageusia
  • or patient COVID PCR-: If patient tested negative by PCR on nasopharyngeal swab, but showing signs suggestive of COVID-19.

排除标准

  • Patient objecting to the use of their data for research purposes
  • Patient under justice or deprived of liberty.

结局指标

主要结局

COVID-PSL Cohort

时间窗: 3 months

measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30

次要结局

未报告次要终点

研究者

发起方
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
申办方类型
Other
责任方
Sponsor

研究点 (1)

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