CClinicalTrials.gg
Status unknownNCT04871685ECOVITAUpdated May 4, 2021

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

An observational study in Respiratory Distress Syndrome, sponsored by University of Campania Luigi Vanvitelli. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by University of Campania Luigi Vanvitelli · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
950
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Distress Syndrome

Keywords

  • lung ultrasound
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 950 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients hospitalized due to COVID19 infection

Inclusion criteria

  • men and women;
  • confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
  • any symptom at hospitalization
  • any therapy
  • any pre-existing comorbidity

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • healthy subjects with other respiratory diseases different from COVID-19
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
950 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testlung 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

06

What researchers measure

Primary outcomes

  1. validation of lung ultrasound score

    validation of lung ultrasound in the clinical practice of diagnosis of complications of low respiratory tracts during COVID-19

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. Association of LUS score with duration of hospitalization (days)

    assessment of LUS score association with hospitalization days

    Time frame: 6 months

  3. Association of LUS score with respiratory support required

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

    Time frame: 6 months

07

Study locations

1 site
  • University of Campania Luigi Vanvitelli
    Naples, Campania 80138, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04871685
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Luca Rinaldi (Researcher, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
May 4, 2021
Start date
Oct 18, 2020
Primary completion
Apr 24, 2021
Completion
May 3, 2021 (estimated)
Last update
May 4, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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