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

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04871685
Collaborator
(none)
950
1
6.5
146.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: lung ultrasound

Study Design

Study Type:
Observational
Actual Enrollment :
950 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
ECOVITA Study. Observational Study on Sars-COV 2 Population Hospitalized in the Italian Country
Actual Study Start Date :
Oct 18, 2020
Actual Primary Completion Date :
Apr 24, 2021
Anticipated Study Completion Date :
May 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Covid Center UOC Vanvitelli, Naples

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Cotugno Hospital, Naples

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center "Del Mare Hospital", Naples

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Santa Maria delle Grazie Hospital, Pozzuoli

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Monaldi Hospital, Naples

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Vannini Hospital, Rome

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Bassini Hospital, ASST Milano Nord

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Melfi Hospital

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Covid Center Messina University Hospital

Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Association of LUS score with duration of hospitalization (days) [6 months]

    assessment of LUS score association with hospitalization days

  3. Association of LUS score with respiratory support required [6 months]

    assessment of LUS score association with requirement of either sub-intensive or intensive therapy)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Campania Luigi Vanvitelli Naples Campania Italy 80138

Sponsors and Collaborators

  • University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luca Rinaldi, Researcher, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier:
NCT04871685
Other Study ID Numbers:
  • Vanvitelli
First Posted:
May 4, 2021
Last Update Posted:
May 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luca Rinaldi, Researcher, University of Campania "Luigi Vanvitelli"
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2021