Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity of Covid-19 Infection

• ClinicalTrials.gov Identifier: NCT04513210
• Recruitment Status: Enrolling by invitation
• First Posted: August 14, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Jagiellonian University
• Information provided by (Responsible Party): Jakub Antczak, Jagiellonian University

Tracking Information

• First Submitted Date: August 11, 2020
• First Posted Date: August 14, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: October 10, 2020
• Estimated Primary Completion Date: October 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2020)

• Relation of changes in ultrasound and progression to respiratory failure [ Time Frame: Through study completion, an average of 1 year. ]
  Comparison of percentage of patients with oxygenation index drop below 300 mmHg during 14 after inclusion between group with and without changes in the ultrasound on admission.
• Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection [ Time Frame: Through study completion, an average of 1 year. ]
  Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group with signs of pneumonia vs. group without signs of pneumonia in the ultrasound, on the day of admission.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 13, 2020)

• Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure [ Time Frame: Through study completion, an average of 1 year. ]
  Correlation of the score reflecting severity of ultrasonographic pneumonia signs with oxygen saturation of arterial blood and with oxygen and carbon dioxide partial pressure in repetitive measurements.
• Sensitivity of ultrasound in detecting interstitial changes in the lungs [ Time Frame: Through study completion, an average of 1 year. ]
  Correlation of the score reflecting severity of ultrasonographic pneumonia signs with the volume of lung interstitium affected by pneumonia, measured in high resolution computer tomography scans.
• Impact change in severity of ultrasonographic pneumonia signs on severity of COVID-19 infection [ Time Frame: Through study completion, an average of 1 year. ]
  Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group which improved and which did not improve in the score reflecting severity of ultrasonographic pneumonia signs from the measurement on the day of admission to measurement five days later.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity of Covid-19 Infection
• Official Title: Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity, Length of Hospitalization and Long-term Complications and of Covid-19 Infection
• Brief Summary: Ultrasound can reliably detect morphologic changes associated with pneumonia. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of long-term pulmonary complications as consequences of Covid-19 pneumonia.
• Detailed Description: Covid-19 pneumonia became the worldwide, serious health problem, affecting nearly 20 million people and causing nearly one million deaths. The health systems of many countries are overwhelmed with the increased need of medical care, of the number of available hospital beds, intensive care beds and ventilators. The proper management of available resources becomes now critical. Ultrasound can reliably detect morphologic changes associated with pneumonia, especially in Covid-19 pneumonia, where the involvement of superficial parts of the lungs predominates. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. Finally, it is much easier to take measures, which minimize the risk of viral transmission between patients for ultrasound equipment than for other lung imaging devices such as x-ray or computer tomography. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of the long-term pulmonary complications as consequences of Covid-19 pneumonia. The study will include repeated ultrasound investigations in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients admitted to the University Hospital in Cracow (Poland) performed during hospitalization and after discharge. The relation of severity and the course of pneumonia revealed by ultrasound to clinical condition, long term complications, use of mechanical ventilation, admission to intensive care and results of laboratory tests will be examined.
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All consecutive patients who will be admitted to the University Hospital in Cracow (Poland) due to Covid-19 infection. University Hospital is one of the largest hospitals in Poland, erving approximately 4,5 million inhabitants of southern Poland.
• Condition: Covid19
• Intervention: Not Provided

Study Groups/Cohorts

• Changes in the lungs on admission
  Patients with Covid-19 infection admitted to the University Hospital with changes in the ultrasound on admission, suggesting pneumonia.
• No changes in the lungs on admission
  Patients with Covid-19 infection admitted to the University Hospital without changes in the ultrasound on admission, suggesting pneumonia.

Publications *

• Liu J, Liu F, Liu Y, Wang HW, Feng ZC. Lung ultrasonography for the diagnosis of severe neonatal pneumonia. Chest. 2014 Aug;146(2):383-388. doi: 10.1378/chest.13-2852.
• Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.
• Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15. Review.
• Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.
• Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: August 13, 2020): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2022
• Estimated Primary Completion Date: October 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients sufficiently medically ill to require hospital admission.
• Confirmed SARS-CoV-2 infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample not earlier than five days prior to inclusion.

Exclusion Criteria:

• Interstitial lung disease in the past.
• Chronic respiratory insufficiency.
• Significant bronchial obstruction n the day of admission to the University Hospital.
• Pulmonary embolism during three months before admission.
• Significant thorax deformity, which may disturb the investigation of the lungs with ultrasound.
• Hemodynamic instability
• Pregnancy (relative contraindication for computer tomography)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT04513210
• Other Study ID Numbers: JagiellonianU67
• 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: Undecided
• Plan Description: Saved ultrasound and computer tomography data, scores of particular ultrasound investigations, volumetric calculations conducted on acquired computer tomography imaging and the records from inpatients and outpatients clinics of University Hospital in Cracow, containing clinical and laboratory data will be available on request sent per e-mail.

• Responsible Party: Jakub Antczak, Jagiellonian University
• Study Sponsor: Jagiellonian University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jakub M Antczak, MD; Jagiellonian University

• PRS Account: Jagiellonian University
• Verification Date: October 2020