Imaging Feature of SARS-CoV2 Infection (COVID19IF)
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|ClinicalTrials.gov Identifier: NCT04394026|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
|Condition or disease|
|Viral Pneumonia COVID|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||COVID-19 Imaging Features|
|Actual Study Start Date :||April 16, 2020|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||October 1, 2020|
- Describe qualitative and quantitative variables [ Time Frame: Through study completion, an average of 5 months ]Evaluate RX imaging aspects at the time of diagnosis and until discharge.
- Describe qualitative and quantitative variables [ Time Frame: 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 progression [ Time Frame: Through study completion, an average of 5 months ]Correlate imaging findings to OS
- Ability of imaging to predict disease evolution [ Time Frame: Through study completion, an average of 5 months ]Correlate imaging findings over time
- Imaging findings and demographic data [ Time Frame: Through study completion, an average of 5 months ]Correlate imaging findings to age and sex
- Imaging findings and laboratory exams [ Time Frame: Through study completion, an average of 5 months ]Correlate imaging findings to laboratory values
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394026
|Contact: Carlo Martinenghi, MDfirstname.lastname@example.org|
|Contact: Francesco De Cobelli, MDemail@example.com|
|Deaprtment of Radiology, IRCCS Ospedale San Raffaele||Recruiting|
|Milano, Italy, 20132|
|Contact: Stephanie Steidler, PhD +390226436111 firstname.lastname@example.org|
|Principal Investigator: Carlo Martinenghi, MD|
|Principal Investigator:||Carlo Martinenghi, MD||IRCCS Ospedale San Raffaele|