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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871685
Recruitment Status : Active, not recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Luca Rinaldi, University of Campania "Luigi Vanvitelli"

Study Description
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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
Respiratory Distress Syndrome Diagnostic Test: lung ultrasound

Study Design
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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 : October 18, 2020
Actual Primary Completion Date : April 24, 2021
Estimated Study Completion Date : May 3, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. validation of lung ultrasound score [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 6 months ]
    assessment of LUS score association with hospitalization days

  3. Association of LUS score with respiratory support required [ Time Frame: 6 months ]
    assessment of LUS score association with requirement of either sub-intensive or intensive therapy)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients hospitalized due to COVID19 infection
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871685


Locations
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Italy
University of Campania Luigi Vanvitelli
Naples, Campania, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
More Information
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Responsible Party: Luca Rinaldi, Researcher, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT04871685    
Other Study ID Numbers: Vanvitelli
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luca Rinaldi, University of Campania "Luigi Vanvitelli":
lung ultrasound
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases