NCT04322487

Brief Summary

Growing evidences are showing the usefulness of lung ultrasound in patients with COVID-19. Sars-CoV-2 has now spread in almost every country in the world. In this study, the investigators share their experience and propose a standardized approach in order to optimize the use of lung ultrasound in covid-19 patients. The investigators focus on equipment, procedure, classification and data-sharing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

April 8, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

March 23, 2020

Last Update Submit

March 7, 2022

Conditions

CoronavirusEpidemic DiseasePneumonia, Viral

Keywords

COVID-19Lung ultrasoundScoreAcquisition protocolInternational standardizationSARS-CoV-2Pneumonia, viral

Outcome Measures

Primary Outcomes (1)

  • Lung ultrasound grading system for COVID-19 pneumonia

    Scoring procedures * Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are present. These artifacts are generally referred as A-lines. * Score 1: The pleura line is indented. Below the indent, vertical areas of white are visible. * Score 2: The pleura line is broken. Below the breaking point, small to large consolidated areas (darker areas) appear with associated areas of white below the consolidated area (white lung). * Score 3: The scanned area shows dense and largely extended white lung with or without larger consolidations At the end of the procedure, the clinician will write for each area the highest score obtained.

    At enrollment.

Interventions

Lung ultrasoundDIAGNOSTIC_TEST

A proposal of a standardized approach in order to optimize the use of lung ultrasound in COVID-19 patients. We focus on equipment, procedure, classification and data-sharing.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspected or known COVID-19 patients.

You may qualify if:

  • suspected COVID-19 patients,
  • known COVID-19 patients.

You may not qualify if:

  • confirmed disease different from COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Bresciamed

Brescia, Italy

Location

Pulmonary Medicine Unit, Lodi General Hospital

Lodi, Italy

Location

118 USL Nordovest Toscana

Lucca, Italy

Location

Diagnostic and Interventional Ultrasound Unit, Valle del Serchio General Hospital

Lucca, Italy

Location

Emergency Department, Fondazione IRCCS Policlinico San Matteo, and Department of Internal Medicine and Therapeutics, University of Pavia

Pavia, Italy

Location

Department of woman and child health and public health, Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Pulmonary Medicine Unit, Dept. Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Department of Information Engineering and Computer Science, Ultrasound Laboratory Trento, University of Trento

Trento, Italy

Location

Emergency Medicine Unit, General Hospital

Voghera, Italy

Location

MeSH Terms

Conditions

Coronavirus InfectionsPneumonia, ViralCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Riccardo Inchingolo, MD, PhD

    Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy

    PRINCIPAL INVESTIGATOR

  • Andrea Smargiassi, MD, PhD

    Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy

    PRINCIPAL INVESTIGATOR

  • Libertario Demi, PhD

    Dept. of Information Engineering and Computer Science, University of Trento, Italy

    PRINCIPAL INVESTIGATOR

  • Gino Soldati, MD

    Diagnostic and Interventional Ultrasound Unit, Valle del Serchio Hospital, Lucca, Italy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 26, 2020

Study Start

April 8, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 8, 2022

Record last verified: 2022-03

Locations

IT(9)