International Lung UltraSound Analysis (ILUSA) Study

NCT04353141 | Unknown

• 1 other identifier: COVID-19: ILUSA (S63988)
• Study Type: observational
• Target: 1,850
• Locations: 3 countries
• Sites: 7

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.

Conditions

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

Keywords

COVID-19; Pregnancy; Diagnosis; Lung ultrasound; Pneumonia; Oxygen support

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of LUS to predict poor outcome

  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

Study Arms (3)

Pregnant patients with confirmed COVID-19 infection

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)

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

Diagnostic Test: standardized Lung Ultrasound (LUS) examination

Interventions

standardized Lung Ultrasound (LUS) examination DIAGNOSTIC_TEST

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; Pregnant patients symptomatic for COVID-19; Pregnant patients with confirmed COVID-19 infection

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Patients with confirmed COVID-19 infection (see below)
• Symptomatic patients suspicious for COVID-19 infection (swab is taken on admission)
• 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)
• 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
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (7)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

University of Brescia

Brescia, Italy

NOT YET RECRUITING

University of Foggia

Foggia, Italy

NOT YET RECRUITING

University of Milan

Milan, Italy

NOT YET RECRUITING

University of Parma

Parma, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario A. Gemelli

Roma, Italy

RECRUITING

Queen Charlotte's & Chelsea Hospital

London, United Kingdom

NOT YET RECRUITING

Related Publications (18)

• Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12.

  PMID: 32151335 BACKGROUND

• Liu D, Li L, Wu X, Zheng D, Wang J, Yang L, Zheng C. Pregnancy and Perinatal Outcomes of Women With Coronavirus Disease (COVID-19) Pneumonia: A Preliminary Analysis. AJR Am J Roentgenol. 2020 Jul;215(1):127-132. doi: 10.2214/AJR.20.23072. Epub 2020 Mar 18.

  PMID: 32186894 BACKGROUND

• Schwartz DA. An Analysis of 38 Pregnant Women With COVID-19, Their Newborn Infants, and Maternal-Fetal Transmission of SARS-CoV-2: Maternal Coronavirus Infections and Pregnancy Outcomes. Arch Pathol Lab Med. 2020 Jul 1;144(7):799-805. doi: 10.5858/arpa.2020-0901-SA.

  PMID: 32180426 BACKGROUND

• Mullins E, Evans D, Viner RM, O'Brien P, Morris E. Coronavirus in pregnancy and delivery: rapid review. Ultrasound Obstet Gynecol. 2020 May;55(5):586-592. doi: 10.1002/uog.22014.

  PMID: 32180292 BACKGROUND

• Liu Y, Chen H, Tang K, Guo Y. Withdrawn: Clinical manifestations and outcome of SARS-CoV-2 infection during pregnancy. J Infect. 2020 Mar 5:S0163-4453(20)30109-2. doi: 10.1016/j.jinf.2020.02.028. Online ahead of print.

  PMID: 32145216 BACKGROUND

• Poon LC, Yang H, Lee JCS, Copel JA, Leung TY, Zhang Y, Chen D, Prefumo F. ISUOG Interim Guidance on 2019 novel coronavirus infection during pregnancy and puerperium: information for healthcare professionals. Ultrasound Obstet Gynecol. 2020 May;55(5):700-708. doi: 10.1002/uog.22013. Epub 2020 Mar 20. No abstract available.

  PMID: 32160345 BACKGROUND

• Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. 2020 May;222(5):415-426. doi: 10.1016/j.ajog.2020.02.017. Epub 2020 Feb 24.

  PMID: 32105680 BACKGROUND

• Liang H, Acharya G. Novel corona virus disease (COVID-19) in pregnancy: What clinical recommendations to follow? Acta Obstet Gynecol Scand. 2020 Apr;99(4):439-442. doi: 10.1111/aogs.13836. Epub 2020 Mar 5. No abstract available.

  PMID: 32141062 BACKGROUND

• Hao W, Li M. Clinical diagnostic value of CT imaging in COVID-19 with multiple negative RT-PCR testing. Travel Med Infect Dis. 2020 Mar-Apr;34:101627. doi: 10.1016/j.tmaid.2020.101627. Epub 2020 Mar 13. No abstract available.

  PMID: 32179123 BACKGROUND

• Pan Y, Guan H, Zhou S, Wang Y, Li Q, Zhu T, Hu Q, Xia L. Initial CT findings and temporal changes in patients with the novel coronavirus pneumonia (2019-nCoV): a study of 63 patients in Wuhan, China. Eur Radiol. 2020 Jun;30(6):3306-3309. doi: 10.1007/s00330-020-06731-x. Epub 2020 Feb 13.

  PMID: 32055945 BACKGROUND

• Bernheim A, Mei X, Huang M, Yang Y, Fayad ZA, Zhang N, Diao K, Lin B, Zhu X, Li K, Li S, Shan H, Jacobi A, Chung M. Chest CT Findings in Coronavirus Disease-19 (COVID-19): Relationship to Duration of Infection. Radiology. 2020 Jun;295(3):200463. doi: 10.1148/radiol.2020200463. Epub 2020 Feb 20.

  PMID: 32077789 BACKGROUND

• Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.

  PMID: 32083985 BACKGROUND

• Fang Y, Zhang H, Xie J, Lin M, Ying L, Pang P, Ji W. Sensitivity of Chest CT for COVID-19: Comparison to RT-PCR. Radiology. 2020 Aug;296(2):E115-E117. doi: 10.1148/radiol.2020200432. Epub 2020 Feb 19. No abstract available.

  PMID: 32073353 BACKGROUND

• Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.

  PMID: 32166346 BACKGROUND

• Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. Is There a Role for Lung Ultrasound During the COVID-19 Pandemic? J Ultrasound Med. 2020 Jul;39(7):1459-1462. doi: 10.1002/jum.15284. Epub 2020 Apr 7. No abstract available.

  PMID: 32198775 BACKGROUND

• Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.

  PMID: 32203708 BACKGROUND

• Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. Proposal for International Standardization of the Use of Lung Ultrasound for Patients With COVID-19: A Simple, Quantitative, Reproducible Method. J Ultrasound Med. 2020 Jul;39(7):1413-1419. doi: 10.1002/jum.15285. Epub 2020 Apr 13.

  PMID: 32227492 BACKGROUND

• Moro F, Buonsenso D, Moruzzi MC, Inchingolo R, Smargiassi A, Demi L, Larici AR, Scambia G, Lanzone A, Testa AC. How to perform lung ultrasound in pregnant women with suspected COVID-19. Ultrasound Obstet Gynecol. 2020 May;55(5):593-598. doi: 10.1002/uog.22028.

  PMID: 32207208 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications, Infectious; Pneumonia; Pneumonia, Viral; COVID-19; Disease

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Hannes Van der Merwe, MD

CONTACT

+32 16 341732; Hannes.vandermerwe@uzleuven.be

Wouter Froyman, MD

CONTACT

+32 16 342612; wouter.froyman@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: April 28, 2020
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); BE (1); GB (1)