NCT05181696

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2024

Enrollment Period

5.3 years

First QC Date

January 4, 2022

Last Update Submit

September 4, 2024

Conditions

Keywords

COVID-19Acute respiratory distress syndrome (ARDS)SepsisMultiorgan FailureChest X-rayInflammation

Outcome Measures

Primary Outcomes (2)

  • Chest x-ray severity score

    The influence of the dynamics of radiographic changes quantified by Brixia score on the outcome of COVID-19 patients will be examined

    21 days

  • Inflammatory markers

    The influence of serum levels of inflammatory parameters, and clinical and laboratory indicators of organic failure on chest x-ray severity score will be examined

    21 days

Study Arms (1)

COVID-19 pneumonia patients

Patients treated at the University Hospital Osijek Respiratory Center with pneumonia caused by SARS-CoV-2

Diagnostic Test: Chest X-ray

Interventions

Chest X-rayDIAGNOSTIC_TEST

Retrospective analysis of chest x-rays of patients with COVID-19

COVID-19 pneumonia patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients treated in ICU COVID-19 with a diagnosis of pneumonia will be analyzed retrospectively.

You may qualify if:

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

You may not qualify if:

  • \- Patients with lung tumors or history of lung resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Osijek

Osijek, 31000, Croatia

RECRUITING

Related Publications (5)

  • 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.

    PMID: 33661992BACKGROUND
  • 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.

    PMID: 32860214BACKGROUND
  • 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.

    PMID: 33778183BACKGROUND
  • 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.

    PMID: 32358689BACKGROUND
  • 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.

    PMID: 32358691BACKGROUND

MeSH Terms

Conditions

SepsisPneumoniaMultiple Organ FailureCOVID-19Respiratory Distress SyndromeInflammation

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesShockPneumonia, ViralVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsRespiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Nenad Nešković, PhD

    University Hospital Osijek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nenad Nešković, PhD

CONTACT

Ivana Haršanji Drenjančević, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 6, 2022

Study Start

January 1, 2020

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-07

Locations