International Lung UltraSound Analysis (ILUSA) Study (ILUSA)

May 5, 2020 updated by: Dirk Timmerman, KU Leuven

A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic

Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room.

The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During the current COVID-19 outbreak, all patient groups have been affected, also the most fragile such as the pregnant women. Although experts provided general suggestions on the best management of pregnant women with suspected or confirmed COVID-19, these considerations are mainly based on retrospective studies or case series. No prospective study is currently available about management of confirmed or suspected patients during pregnancy. Moreover, only limited outcome data is available on the management of asymptomatic SARS-CoV-2 positive pregnant patients, many of whom subsequently develop disease symptoms.

The current gold standard for the etiological diagnosis of COVID-19 infection is analysis of respiratory tract specimens by (real-time) reverse transcription polymerase chain reaction (RT-PCR). However, this test has a high false-negative rate, due to both nasopharyngeal swab sampling error, which often requires repeat sampling, and changing viral burden. Currently, high-resolution computed tomography (CT) is the main tool for primary diagnosis and evaluation of disease severity in patients affected by COVID-19 infection. Chest CT scan also demonstrated a specificity even superior to the nasal/pharyngeal swab for diagnosis. Yet, radiation exposure should ideally be avoided at all times in pregnancy. A radiation-free point-of-care diagnostic tool, such as lung ultrasound (LUS) examination, would be particularly useful for assessing the lungs of pregnant women. Indeed, LUS examination has recently been suggested by the Chinese Critical Care Ultrasound Study Group and the Italian Academy of Thoracic Ultrasound as an accurate tool to detect lung involvement during COVID-19.

In pregnant patients, LUS could be a valid alternative imaging tool to thoracic CT to guarantee appropriate care for these patients. Symptomatic patients with a low risk of developing serious disease may be possibly reassured, and could leave the hospital soon after delivery. On the other hand LUS could possibly indicate patients at higher risk for future need of oxygen or ventilation support, and who might need more careful monitoring and longer hospitalization. In view of the wide availability in delivery suites, the low cost and easy bedside application LUS could also be readily repeated during patient follow up as needed. LUS has been traditionally employed by non-radiologists as an adjunctive clinical instrument. Obstetricians represent a category of clinicians who use ultrasound in their daily routine practice. From a technical point of view, examination of the lungs at the time of obstetric ultrasound evaluation could be feasible for obstetricians and gynaecologists.

Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, LUS can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room.

The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.

Study Type

Observational

Enrollment (Anticipated)

1850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:
          • Hannes Van der Merwe, PhD
  • Italy
      • Brescia, Italy
        • Not yet recruiting
        • University of Brescia
        • Contact:
          • Federico Prefumo
      • Foggia, Italy
        • Not yet recruiting
        • University of Foggia
        • Contact:
          • Francesco D'Antonio
      • Milan, Italy
        • Not yet recruiting
        • University of Milan
        • Contact:
          • Irene Cetin
      • Parma, Italy
        • Not yet recruiting
        • University of Parma
        • Contact:
          • Tiziana Frusca
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli
        • Contact:
          • Antonia Testa, PhD
        • Sub-Investigator:
          • Francesca Moro
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Queen Charlotte's & Chelsea Hospital
        • Contact:
          • Tom Bourne, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All consecutive pregnant patients who are admitted to the hospital for delivery, cesarean section or admission for at least one night.

Description

Inclusion Criteria:

Participants eligible for inclusion in this Trial must meet all of the following criteria:

Voluntary written informed consent of the participant or their legally authorized representative obtained prior to any screening procedures

Pregnant patients admitted to the Hospital during the COVID-19 pandemic:

  1. Patients with confirmed COVID-19 infection (see below)
  2. Symptomatic patients suspicious for COVID-19 infection (swab is taken on admission)
  3. Patients asymptomatic for COVID19 with other feto-maternal diseases or who come for delivery or caesarean section

All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.

Definition of suspected case (WHO guideline, ISUOG)

  1. A patient with acute respiratory illness (fever and at least one sign/symptom of respiratory disease (e.g. cough, shortness of breath)) AND with no other etiology that fully explains the clinical presentation AND a history of travel to or residence in a country/area or territory reporting local transmission of COVID-19 infection during the 14 days prior to symptom onset; OR
  2. A patient with any acute respiratory illness AND who has been in contact with a confirmed or probable case of COVID-19 infection in the 14 days prior to onset of symptoms; OR
  3. A patient with severe acute respiratory infection (fever and at least one sign/symptom of respiratory disease (e.g. cough, shortness breath)) AND who requires hospitalization AND who has no other etiology that fully explains the clinical presentation.

Exclusion Criteria:

Participants eligible for this Trial must not meet any of the following criteria:

  • Maternal lung pre-existing disease
  • Maternal cardiac problems
  • Severely ill patients in unstable condition requiring immediate life-saving procedures

Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled in the Trial and will be identified on the Screening Log as Screen Failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant patients with confirmed COVID-19 infection
Diagnostic test: standardized Lung Ultrasound (LUS) examination
14 areas (three posterior, two lateral and two anterior) will be assigned a COVID-LUS score: Score 0 (Normal pattern), Score 1 (Pattern of mild disease), Score 2 (Pattern of moderate disease), Score 3 (Pattern of severe disease). Classification of LUS result: LUS NEGATIVE: Group A = Score 0 in all 14 areas OR score =1 in areas of one site (right or left). It means that score 1 is pathological only when present bilaterally; LUS POSITIVE: both group B and C have to be considered positive: Group B (MILD DISEASE) = Score 1 in at least two areas localized bilaterally and no areas with score >1; Group C (MODERATE/SEVERE DISEASE)= Score >2 in at least two areas localized bilaterally
Pregnant patients symptomatic for COVID-19
Symptomatic patients suspicious for COVID-19 infection (swab is taken on admission)
Diagnostic test: standardized Lung Ultrasound (LUS) examination
14 areas (three posterior, two lateral and two anterior) will be assigned a COVID-LUS score: Score 0 (Normal pattern), Score 1 (Pattern of mild disease), Score 2 (Pattern of moderate disease), Score 3 (Pattern of severe disease). Classification of LUS result: LUS NEGATIVE: Group A = Score 0 in all 14 areas OR score =1 in areas of one site (right or left). It means that score 1 is pathological only when present bilaterally; LUS POSITIVE: both group B and C have to be considered positive: Group B (MILD DISEASE) = Score 1 in at least two areas localized bilaterally and no areas with score >1; Group C (MODERATE/SEVERE DISEASE)= Score >2 in at least two areas localized bilaterally
Pregnant patients asymptomatic for COVID19
Patients asymptomatic for COVID19 with other feto-maternal diseases or who come for delivery or caesarean section
Diagnostic test: standardized Lung Ultrasound (LUS) examination
14 areas (three posterior, two lateral and two anterior) will be assigned a COVID-LUS score: Score 0 (Normal pattern), Score 1 (Pattern of mild disease), Score 2 (Pattern of moderate disease), Score 3 (Pattern of severe disease). Classification of LUS result: LUS NEGATIVE: Group A = Score 0 in all 14 areas OR score =1 in areas of one site (right or left). It means that score 1 is pathological only when present bilaterally; LUS POSITIVE: both group B and C have to be considered positive: Group B (MILD DISEASE) = Score 1 in at least two areas localized bilaterally and no areas with score >1; Group C (MODERATE/SEVERE DISEASE)= Score >2 in at least two areas localized bilaterally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of LUS to predict poor outcome
Time Frame: outcome one week after enrollment into the study

The primary endpoint is diagnostic performance in terms of the area under the receiver operating characteristic curve (AUC, also known as the c-statistic) and sensitivity and specificity with regard to the prediction of poor outcome.

Outcome at one week from admission: good outcome includes discharge or inpatient breathing in free air; poor outcome includes patient with oxygen support, patients with CPAP/ high oxygen flow cannula, or patient with endotracheal intubation during the week.
outcome one week after enrollment into the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Study Chair: Dirk Timmerman, PhD, KU Leuven, Leuven BE
  • Study Chair: Antonia Testa, PhD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT
  • Study Chair: Jan Deprest, PhD, KU Leuven
  • Study Chair: Francesca Moro, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT
  • Study Chair: Tom Bourne, PhD, Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UK
  • Study Chair: Giovanni Scambia, PhD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT
  • Study Chair: Antonio Lanzone, PhD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Anticipated)

May 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19: ILUSA (S63988)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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