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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
Sponsor:
Information provided by (Responsible Party):
Francesco De Cobelli, IRCCS San Raffaele

Brief Summary:
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.

Condition or disease
Viral Pneumonia COVID

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Ability of imaging to predict disease progression [ Time Frame: Through study completion, an average of 5 months ]
    Correlate imaging findings to OS

  4. Ability of imaging to predict disease evolution [ Time Frame: Through study completion, an average of 5 months ]
    Correlate imaging findings over time


Secondary Outcome Measures :
  1. Imaging findings and demographic data [ Time Frame: Through study completion, an average of 5 months ]
    Correlate imaging findings to age and sex

  2. Imaging findings and laboratory exams [ Time Frame: Through study completion, an average of 5 months ]
    Correlate imaging findings to laboratory values



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with proven COVID-19
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not fulfilling any of the above

Information from the National Library of Medicine

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


Contacts
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Contact: Carlo Martinenghi, MD +390226432529 martinenghi.carlo@hsr.it
Contact: Francesco De Cobelli, MD +390226432529 decobelli.francesco@hsr.it

Locations
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Italy
Deaprtment of Radiology, IRCCS Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Contact: Stephanie Steidler, PhD    +390226436111    steidler.stephanie@hsr.it   
Principal Investigator: Carlo Martinenghi, MD         
Sponsors and Collaborators
Francesco De Cobelli
Investigators
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Principal Investigator: Carlo Martinenghi, MD IRCCS Ospedale San Raffaele
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Responsible Party: Francesco De Cobelli, MD, Chair Radiology Department, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04394026    
Other Study ID Numbers: COVID-19 IF
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco De Cobelli, IRCCS San Raffaele:
diagnosis
disease progression
imaging features
SARS-CoV2
COVID
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases