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临床试验/NCT04422613
NCT04422613已完成不适用

Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Alteration of the DLCO

研究概览

简要总结

Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease.

Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease.

The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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 with COVID-19 pneumonia
  • Positive PCR for COVID-19 on respiratory sample (saliva, nasopharyngeal, bronchial, tracheal aspiration or LBA)
  • Having required hospitalization in the pulmonology service, intensive care in pneumology or resuscitation service at the Toulouse University Hospital
  • Saturation <94% in ambient air at diagnosis
  • Patient having a chest CT-scan proving pneumonia during his hospitalization
  • Patient ≥ 18 years old
  • Patient who has given written consent to participate in the study

排除标准

  • Patient hospitalized for pneumonia not documented by a chest CT-scan
  • Patient with negative COVID PCR
  • Patient known before the episode of COVID-19 pneumonia for a respiratory or cardiac pathology which can lead in itself to an alteration of gas exchanges
  • Patient under curators / guardianship
  • Pregnant patient
  • Minor patient
  • Absence of consent for participation in the study
  • Medical condition that does not allow for pulmonary function test

结局指标

主要结局

Alteration of the DLCO

时间窗: 4 month

Alteration of the DLCO test defined by a corrected DLCO value \<70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2)

次要结局

  • Measurement on lung volumes(4 month)
  • Persistent respiratory anomalies(12 month)
  • Respiratory symptom(4 month)
  • Bronchial or ventilatory anomalies(4 month)
  • Mechanism of the alteration of gas exchanges(4 month)
  • mechanism of the alteration of gas exchanges by chest scan(4 month)
  • mechanism of the alteration of gas exchanges by scintigraphy(4 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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