The ECOVITA Study - Validation of LUS Score in SARS-CoV-2 Disease, i.e COVID-19

Study Overview
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Brief Summary
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Lung Ultrasound (LUS) has been revealing an extremely useful tool to identify and monitor complications from Sars-COV-2 disease. Recently, a research group has proposed a score, named LUS Score, able to optimize the use of this diagnostic technique. LUS Score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (B lines), the characteristics of the pleural line and the presence or not of consolidation areas. The comparison between LUS and chest tomography (CT), the current gold standard for the diagnosis of interstitial pneumonia by COVID-19, has confirmed from the preliminary data, the reliability of such technique. Hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.

Official Title
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ECOVITA Study. Observational Study on Sars-COV 2 Population Hospitalized in the Italian Country

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Diagnostic Test: lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women; confirmed COVID19 diagnosis after nasal-oropharyngeal swab; any symptom at hospitalization any therapy any pre-existing comorbidity Exclusion Criteria: pregnant women healthy subjects with other respiratory diseases different from COVID-19

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid Center UOC Vanvitelli, Naples<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Cotugno Hospital, Naples<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Del Mare Hospital, Naples<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Santa Maria delle Grazie Hospital, Pozzuoli<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Monaldi Hospital, Naples<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Vannini Hospital, Rome<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Bassini Hospital, ASST Milano Nord<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Melfi Hospital<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|
| Covid Center Messina University Hospital<br>Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units | Diagnostic Test: lung ultrasound<br>* the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validation of lung ultrasound score | validation of lung ultrasound in the clinical practice of diagnosis of complications of low respiratory tracts during COVID-19 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of LUS score with clinical outcome | assessment of LUS score association with the clinical course of disease (final outcome, either discharged or in-hospital mortality | 6 months | 
| Association of LUS score with duration of hospitalization (days) | assessment of LUS score association with hospitalization days | 6 months | 
| Association of LUS score with respiratory support required | assessment of LUS score association with requirement of either sub-intensive or intensive therapy) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung ultrasound