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临床试验/NCT04817293
NCT04817293Unknown不适用

Coordinated Research on Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With SARS-COV-2 Infection: a Transversal Study in Town in the Hauts de France Region

Tourcoing Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年4月6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
To compare the reasons for consultation between patients with a history of Covid 19 and those who have not been infected with SARS-CoV-2.

研究概览

简要总结

Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).

The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19

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

  • A- For COVID cases:
  • Consultation in a city doctor's office
  • Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
  • Patient symptomatic or not
  • Definition of symptomatic :
  • OR CT scan suggestive of COVID 19
  • OR ≥ 2 symptoms contemporaneous with virologic sampling among: asthenia, cough, dyspnea, fever, myalgias, dysgeusia, diarrhea AND not present previously at diagnosis
  • B-. For NON COVID cases:
  • Consultation in a city doctor's office
  • No known COVID+ serology
  • No known RT- PCR SARS-CoV-2
  • No clinical suspicion of COVID-19 infection

排除标准

  • Minor patient
  • Refusal to participate
  • Patient under protection
  • Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)
  • Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge

结局指标

主要结局

To compare the reasons for consultation between patients with a history of Covid 19 and those who have not been infected with SARS-CoV-2.

时间窗: At day 1

The judgement criterion will be the reasons for consultation standardized with the CISP-2 classification (International Classification of Primary Care).

次要结局

  • To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.(At day 1)
  • To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.(At day 1)

研究者

发起方
Tourcoing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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