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临床试验/NCT04483752
NCT04483752Unknown不适用

Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images

Centre Chirurgical Marie Lannelongue5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
5
主要终点
description of the different types of lesions

研究概览

简要总结

The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients.

The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections.

The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy".

In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.

The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).

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 hospitalized for SARS CoV-2 infection proved by RT-PCR and/or by a typical SARS CoV-2 pneumonia clinic and imaging that required hospitalization Scan performed when the patient is no longer oxygenating, i.e. at least 48 hours prior to hospital discharge (discharge criterion) up to a maximum of 1 month after hospitalisation.
  • Patient ≥ 18 years old
  • Patient who has given free, informed and written consent

排除标准

  • Patient ≤ 18 years old
  • CT Contraindication
  • Pregnant or breastfeeding woman

结局指标

主要结局

description of the different types of lesions

时间窗: 3 months

次要结局

  • quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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