International Lung UltraSound Analysis (ILUSA) Study

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.

Conditions

• COVID
• Pregnancy Complications, Infectious
• Pregnancy Related
• Pregnancy, High Risk
• Pregnancy Disease
• Pneumonia
• Pneumonia, Viral
• Diagnoses Disease

Interventions

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

Sponsors & Collaborators

• KU Leuven

  lead OTHER

Principal Investigators

• Dirk Timmerman, PhD · KU Leuven, Leuven BE

• Antonia Testa, PhD · Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT

• Jan Deprest, PhD · KU Leuven

• Francesca Moro, MD · Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT

• Tom Bourne, PhD · Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UK

• Giovanni Scambia, PhD · Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT

• Antonio Lanzone, PhD · Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome IT

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-28

Primary Completion

2020-05-31

Completion

2020-12-31

Countries

• Belgium
• Italy
• United Kingdom

Study Locations