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临床试验/NCT04394026
NCT04394026已完成不适用

COVID-19 Imaging Features

Francesco De Cobelli1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月16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
200
试验地点
1
主要终点
Ability of imaging to predict disease progression

研究概览

简要总结

The novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical disease with respiratory failure, shock or multi-organ failure in particular patient cohorts. Imaging plays a key role is diagnosis and progression of this disease.

详细描述

In March 2020, the third highest number of positive cases in the world was recorded in Italy, mainly due to 2 outbreaks of 2 different clusters in Lombardy and Veneto.

Fever is the most common symptom, followed by fatigue and dry cough; worsening of dyspnea and acute respiratory distress syndrome are found in severe cases. Previous reports have highlighted the key role of chest computed tomography (CT) and chest X-ray (CXR) in the diagnosis and follow-up of CoViD-19.

The most frequent clinical manifestation seems to be viral pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely: with evidence of mild disease in the majority of confirmed cases, severe pneumonia on a part of these, defined as dyspnea, hypoxia or lung involvement > 40% at imaging within 24-48 hours, and critical disease defined as respiratory failure, shock or multi-organ failure in particular patient cohorts.The mortality rate between cases ranges from approximately 4% in early reports to 14%, depending on the intensity of transmission and time of infection, and most fatal cases occurred in older patients or in patients with pre-existing medical co-morbidities.

Imaging plays an essential role in the diagnosis and follow-up of this infection.Several studies have been published describing the results of imaging, mainly using chest CT (computed tomography) with a limited number of articles describing disease in European patients or the possible different clinical/radiological presentation of the disease in European patients.

Pulmonary pathological findings appear to be similar to those previously described in SARS and MERS, with a prevalence of frosted glass densities and occasional consolidation.According to the literature, the 3 main features for the diagnosis of CoVid-19 pneumonia are: alveolar disease, represented by ground glass densities, bilateral distribution and prevalent peripheral involvement. This triad is more common in intermediate stages of the disease. In the early stages of the disease, a significant proportion of patients may present with negative or dubious X-rays and CT scans.There is an important overlap with imaging findings of other viral pneumonia, in particular with other members of the coronaviridae family: consolidation, however, seems to be less common in the early stages of CoViD-19 and bilateral distribution is less frequent in SARS and MERS pneumonia. Very little data have been published on the radiological evolution and modification of radiological aspects during infection: as the disease progresses, parenchymal consolidations begin to resorb and assume a frosted glass appearance. Another possible evolution is the progression towards the radiological aspect of the "white lung". This study aims to describe imaging aspects of CoViD-19 infection in Italian patients and the data on the radiological evolution.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • CoViD-19 positive patients (rRT-PCR naso-pharyngeal swab)
  • Suspicion of SARS-CoV2 on chest X-ray and/or chest CT presentation of disease
  • Patients of all ages
  • Subjects at risk (minors, patients in emergency situations, pregnant women, potentially incapable of giving their consent )
  • Having signed the Informed Consent

排除标准

  • Not fulfilling any of the above

结局指标

主要结局

Ability of imaging to predict disease progression

时间窗: Through study completion, an average of 5 months

Correlate imaging findings to OS

Describe qualitative and quantitative variables

时间窗: Through study completion, an average of 5 months

Evaluate CT imaging aspects at the time of diagnosis and until discharge.

Ability of imaging to predict disease evolution

时间窗: Through study completion, an average of 5 months

Correlate imaging findings over time

次要结局

  • Imaging findings and laboratory exams(Through study completion, an average of 5 months)
  • Imaging findings and demographic data(Through study completion, an average of 5 months)

研究者

发起方
Francesco De Cobelli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francesco De Cobelli

MD, Chair Radiology Department

IRCCS San Raffaele

研究点 (1)

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