Clinical trial NCT05181696: Retrospective Analysis of Chest X-ray Severity Scoring System of COVID-19 Pneumonia
Official title: Radiographic Severity Scoring System and Clinical and Laboratory Evolution of COVID-19 Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Pneumonia
Sepsis
SARS-CoV-2 Acute Respiratory Disease
Pneumonia
Multiorgan Failure
Keywords: COVID-19
Acute respiratory distress syndrome (ARDS)
Sepsis
Multiorgan Failure
Chest X-ray
Inflammation
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated in ICU COVID-19 with a diagnosis of pneumonia will be analyzed retrospectively.

Brief summary: The research will be retrospective, and will include all patients who were admitted during 2020 and 2021 in the COVID-19 ICU of University Hospital Center Osijek due to pneumonia caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The association of chest x-ray infiltrate evolution with changes in laboratory inflammatory parameters and respiratory function parameters will be examined.

Detailed description: The research will be retrospective, and will include a review of medical history of all patients admitted in the COVID-19 ICU of the University hospital Osijek during 2020 and 2021. Associated comorbidity, hospital admission date, intubation date, mechanical ventilation, extubation, discharge, and patient final outcome will be recorded for each patient. By analyzing X-rays of the lungs by radiology specialists, inflammatory infiltrates in the lungs will be quantified via the Brixia system, during hospital admission, admission to the Respiratory Center, and during treatment at the Respiratory Center. All patients will have their Sequential Organ Failure Assessment (SOFA) and/or Acute Physiology and Chronic Health Evaluation (APACHE II) values calculated upon admission. Inflammatory parameters (c-reactive protein (CRP), procalcitonin (PCT), interleukine-6 (IL-6), ferritin), red blood cell count, leukocytes, blood urea nitrogen (BUN), arterial blood gases and ventilation parameters on admission to the hospital, admission to the ICU, and on several occasions during treatment in the ICU will be analysed. Also, empirical use of antibiotics, the occurrence of bacterial superinfections, sepsis and organic failure will be noted.

Eligibility criteria: Inclusion Criteria:

* Pneumonia caused by SARS-CoV-2 virus
* Admission to the ICU COVID-19 unit

Exclusion Criteria:

- Patients with lung tumors or history of lung resection

Primary outcomes:
measure: Chest x-ray severity score
timeFrame: 21 days
measure: Inflammatory markers
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University hospital Osijek
Study officials:
affiliation: University Hospital Osijek
name: Nenad Nešković, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Booth A, Reed AB, Ponzo S, Yassaee A, Aral M, Plans D, Labrique A, Mohan D. Population risk factors for severe disease and mortality in COVID-19: A global systematic review and meta-analysis. PLoS One. 2021 Mar 4;16(3):e0247461. doi: 10.1371/journal.pone.0247461. eCollection 2021.
citation: Wolff D, Nee S, Hickey NS, Marschollek M. Risk factors for Covid-19 severity and fatality: a structured literature review. Infection. 2021 Feb;49(1):15-28. doi: 10.1007/s15010-020-01509-1. Epub 2020 Aug 28.
citation: Mahat RK, Panda S, Rathore V, Swain S, Yadav L, Sah SP. The dynamics of inflammatory markers in coronavirus disease-2019 (COVID-19) patients: A systematic review and meta-analysis. Clin Epidemiol Glob Health. 2021 Jul-Sep;11:100727. doi: 10.1016/j.cegh.2021.100727. Epub 2021 Mar 20.
citation: Borghesi A, Maroldi R. COVID-19 outbreak in Italy: experimental chest X-ray scoring system for quantifying and monitoring disease progression. Radiol Med. 2020 May;125(5):509-513. doi: 10.1007/s11547-020-01200-3. Epub 2020 May 1.
citation: Borghesi A, Zigliani A, Masciullo R, Golemi S, Maculotti P, Farina D, Maroldi R. Radiographic severity index in COVID-19 pneumonia: relationship to age and sex in 783 Italian patients. Radiol Med. 2020 May;125(5):461-464. doi: 10.1007/s11547-020-01202-1. Epub 2020 May 1.