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

Respiratory Distress Syndrome Clinical Trial

— ECOVITA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04871685
• Other study ID #: Vanvitelli
• Status: Active, not recruiting
• Start date: October 18, 2020
• Est. completion date: May 3, 2021

Study information

• Verified date: May 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 950
• Est. completion date: May 3, 2021
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Diagnostic Test:
• lung ultrasound
the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19

Locations

Country	Name	City	State
Italy	University of Campania Luigi Vanvitelli	Naples	Campania

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Association of LUS score with duration of hospitalization (days)	assessment of LUS score association with hospitalization days	6 months
Secondary	Association of LUS score with respiratory support required	assessment of LUS score association with requirement of either sub-intensive or intensive therapy)	6 months