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International Lung UltraSound Analysis (ILUSA) Study (ILUSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353141
Recruitment Status : Unknown
Verified May 2020 by Dirk Timmerman, KU Leuven.
Recruitment status was:  Recruiting
First Posted : April 20, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk Timmerman, KU Leuven

Tracking Information
First Submitted Date April 16, 2020
First Posted Date April 20, 2020
Last Update Posted Date May 7, 2020
Actual Study Start Date April 28, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2020)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Lung UltraSound Analysis (ILUSA) Study
Official Title A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID
  • Pregnancy Complications, Infectious
  • Pregnancy Related
  • Pregnancy, High Risk
  • Pregnancy Disease
  • Pneumonia
  • Pneumonia, Viral
  • Diagnoses Disease
Intervention 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
Study Groups/Cohorts
  • Pregnant patients with confirmed COVID-19 infection
    Intervention: Diagnostic Test: standardized Lung Ultrasound (LUS) examination
  • Pregnant patients symptomatic for COVID-19
    Symptomatic patients suspicious for COVID-19 infection (swab is taken on admission)
    Intervention: Diagnostic Test: standardized Lung Ultrasound (LUS) examination
  • Pregnant patients asymptomatic for COVID19
    Patients asymptomatic for COVID19 with other feto-maternal diseases or who come for delivery or caesarean section
    Intervention: Diagnostic Test: standardized Lung Ultrasound (LUS) examination
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 16, 2020)		 1850
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04353141
Other Study ID Numbers COVID-19: ILUSA (S63988)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Dirk Timmerman, KU Leuven
Original Responsible Party Same as current
Current Study Sponsor KU Leuven
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account KU Leuven
Verification Date May 2020