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临床试验/NCT04443257
NCT04443257终止不适用

REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2020年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
119
试验地点
1
主要终点
Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry

研究概览

简要总结

Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2 infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

详细描述

Since sars-cov-2 ("CoVID-19") is a newly defined infection, its sequelae and short-term medical and psychological impact remain poorly described.The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

Indeed, some patients may develop chronic respiratory failure, pulmonary fibrosis, or other comorbidities including cardiovascular or metabolic diseases. The psychological impact is also essential to assess. The sequelae and comorbidities of patients could also vary depending on the severity of the initial acute involvement.

Investigators propose to explore the sequelae of patients who have been hospitalized for acute sars-cov-2 infection, between 3 to 6 months after discharge from hospital, by characterizing the incidence of chronic respiratory failure and fibrosis, as well as of various comorbidities such as cardiovascular, metabolic, and psychological diseases.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient who was hospitalized within 3 to 6 months for a sars-CoV infection

排除标准

  • Absence of signed informed consent
  • pregnancy or breastfeeding
  • patient under guardianship or curatorship

结局指标

主要结局

Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry

时间窗: 3 to 6 months after Sars coV 2 infection

次要结局

  • Incidence or worsening of renal disease(3 to 6 months after Sars coV 2 infection)
  • Incidence or worsening of liver disease(3 to 6 months after Sars coV 2 infection)
  • Assessment of dyspnea(3 to 6 months after Sars coV 2 infection)
  • Development of pulmonary fibrosis as assessed by lung CT scan(3 to 6 months after Sars coV 2 infection)
  • Incidence or worsening of cardiovascular diseases(3 to 6 months after Sars coV 2 infection)
  • Incidence or worsening of psychological pathology : anxiety(3 to 6 months after Sars coV 2 infection)
  • Incidence or worsening of psychological pathology: post-traumatic stress(3 to 6 months after Sars coV 2 infection)
  • Determination of risk factors associated with sequelae or comorbidities(3 to 6 months after Sars coV 2 infection)
  • Description of pulmonary lesions as assessed by lung CT scan(3 to 6 months after Sars coV 2 infection)
  • Incidence or worsening of psychological pathology: depression(3 to 6 months after Sars coV 2 infection)
  • Assessment of the socioeconomic deprivation(3 to 6 months after Sars coV 2 infection)
  • Development of auto-immune disorders(3 to 6 months after Sars coV 2 infection)
  • Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile(3 to 6 months after Sars coV 2 infection)
  • Patients' self-reported level of physical activity(3 to 6 months after Sars coV 2 infection)
  • Incidence or worsening of psychological pathology: insomnia(3 to 6 months after Sars coV 2 infection)
  • Assessment of the health-related quality of life(3 to 6 months after Sars coV 2 infection)
  • Assessment of the fatigue(3 to 6 months after Sars coV 2 infection)
  • development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition(3 to 6 months after Sars coV 2 infection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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