NCT04871685

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

April 27, 2021

Last Update Submit

May 1, 2021

Conditions

Keywords

lung ultrasound

Outcome Measures

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

    6 months

Secondary Outcomes (3)

  • Association of LUS score with clinical outcome

    6 months

  • Association of LUS score with duration of hospitalization (days)

    6 months

  • Association of LUS score with respiratory support required

    6 months

Study Arms (9)

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

lung ultrasoundDIAGNOSTIC_TEST

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", NaplesCovid Center Bassini Hospital, ASST Milano NordCovid Center Cotugno Hospital, NaplesCovid Center Melfi HospitalCovid Center Messina University HospitalCovid Center Monaldi Hospital, NaplesCovid Center Santa Maria delle Grazie Hospital, PozzuoliCovid Center UOC Vanvitelli, NaplesCovid Center Vannini Hospital, Rome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients hospitalized due to COVID19 infection

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 4, 2021

Study Start

October 18, 2020

Primary Completion

April 24, 2021

Study Completion

May 3, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations