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

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT04871685
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-18
• Primary Completion: 2021-04-24
• Study First Submitted: 2021-04-27
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-01
• Last Update Submitted: 2021-05-01
• Study Completion: 2021-05-03
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 950

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
validation of lung ultrasound score	6 months	validation of lung ultrasound in the clinical practice of diagnosis of complications of low respiratory tracts during COVID-19

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Campania Luigi Vanvitelli; 🇮🇹 Naples, Campania, Italy