Respiratory Distress SyndromeECOVITANCT04871685
The ECOVITA Study - Validation of LUS Score in SARS-CoV-2 Disease, i.e COVID-19
An observational study of Respiratory Distress Syndrome, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- lung ultrasound
- How many people
- 950 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2020to 3 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized due to COVID19 infection
Who may be able to join
- men and women;
- confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
- any symptom at hospitalization
- any therapy
- any pre-existing comorbidity
Who cannot join
- pregnant women
- healthy subjects with other respiratory diseases different from COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECOVITA Study. Observational Study on Sars-COV 2 Population Hospitalized in the Italian Country
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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- lung ultrasound
- Keywords
- lung ultrasound
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Covid Center UOC Vanvitelli, Naples | Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of lung ultrasound score
validation of lung ultrasound in the clinical practice of diagnosis of complications of low respiratory tracts during COVID-19
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
Association of LUS score with duration of hospitalization (days)
assessment of LUS score association with hospitalization days
Measured: 6 months
Association of LUS score with respiratory support required
assessment of LUS score association with requirement of either sub-intensive or intensive therapy)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start18 Oct 2020
- Primary completion24 Apr 2021
- Study completion3 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Rinaldi, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871685
- Sponsor's protocol ID
- Vanvitelli
- Acronym
- ECOVITA
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECOVITA Study. Observational Study on Sars-COV 2 Population Hospitalized in the Italian Country
- ClinicalTrials.gov ID
- NCT04871685
- Acronym / sponsor ID
- ECOVITA / Vanvitelli
- Conditions
- Respiratory Distress Syndrome
- Keywords
- lung ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 3 May 2021 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Covid Center UOC Vanvitelli, Naples | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Cotugno Hospital, Naples | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center "Del Mare Hospital", Naples | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Santa Maria delle Grazie Hospital, Pozzuoli | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Monaldi Hospital, Naples | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Vannini Hospital, Rome | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Bassini Hospital, ASST Milano Nord | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Melfi Hospital | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
| Covid Center Messina University Hospital | – | Diagnostic Test: lung ultrasoundPatients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized due to COVID19 infection
Key inclusion criteria (5 listed)
- men and women;
- confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
- any symptom at hospitalization
- any therapy
- any pre-existing comorbidity
Key exclusion criteria (2 listed)
- pregnant women
- healthy subjects with other respiratory diseases different from COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasoundthe patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19 | Diagnostic test | Covid Center "Del Mare Hospital", Naples, Covid Center Bassini Hospital, ASST Milano Nord, Covid Center Cotugno Hospital, Naples, Covid Center Melfi Hospital, Covid Center Messina University Hospital, Covid Center Monaldi Hospital, Naples, Covid Center Santa Maria delle Grazie Hospital, Pozzuoli, Covid Center UOC Vanvitelli, Naples, Covid Center Vannini Hospital, Rome |
Primary outcome
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
3 secondary outcomes
Association of LUS score with clinical outcome
Time frame: 6 months
Association of LUS score with duration of hospitalization (days)
Time frame: 6 months
Association of LUS score with respiratory support required
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation of lung ultrasound score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.