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International Lung UltraSound Analysis (ILUSA) Study (ILUSA)

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ClinicalTrials.gov Identifier: NCT04353141
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk Timmerman, KU Leuven

Brief Summary:

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.


Condition or disease Intervention/treatment
COVID Pregnancy Complications, Infectious Pregnancy Related Pregnancy, High Risk Pregnancy Disease Pneumonia Pneumonia, Viral Diagnoses Disease Diagnostic Test: standardized Lung Ultrasound (LUS) examination

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.

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Study Type : Observational
Estimated Enrollment : 1850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.


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): NCT04353141


Contacts
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Contact: Hannes Van der Merwe, MD +32 16 341732 Hannes.vandermerwe@uzleuven.be
Contact: Wouter Froyman, MD +32 16 342612 wouter.froyman@uzleuven.be

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

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Responsible Party: Dirk Timmerman, PhD, KU Leuven
ClinicalTrials.gov Identifier: NCT04353141    
Other Study ID Numbers: COVID-19: ILUSA (S63988)
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
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 Dirk Timmerman, KU Leuven:
COVID-19
Pregnancy
Diagnosis
Lung ultrasound
Pneumonia
Oxygen support
Additional relevant MeSH terms:
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Pregnancy Complications, Infectious
Pneumonia, Viral
Pneumonia
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Virus Diseases