COVID-19 PneumoniaRANCH-COVIDNCT05181696
Retrospective Analysis of Chest X-ray Severity Scoring System of COVID-19 Pneumonia
An observational study of COVID-19 Pneumonia and Sepsis, run by Osijek University Hospital at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 Pneumonia, Sepsis, SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Chest X-ray
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2020to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated in ICU COVID-19 with a diagnosis of pneumonia will be analyzed retrospectively.
Who may be able to join
- Pneumonia caused by SARS-CoV-2 virus
- Admission to the ICU COVID-19 unit
Who cannot join
- Patients with lung tumors or history of lung resection
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University hospital Osijek
Osijek, 31000
Nenad Nešković, PhD, +385996787250, nneskov@gmail.com
About this study
Official title: Radiographic Severity Scoring System and Clinical and Laboratory Evolution of COVID-19 Pneumonia
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia, Sepsis, SARS-CoV-2 Acute Respiratory Disease, Pneumonia, Multiorgan Failure
- Being tested
- Chest X-ray
- Keywords
- COVID-19, Acute respiratory distress syndrome (ARDS), Sepsis, Multiorgan Failure, Chest X-ray, Inflammation
- Medical subject headings
- Sepsis, Pneumonia, Multiple Organ Failure, COVID-19, Respiratory Distress Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest X-rayDiagnostic test
Retrospective analysis of chest x-rays of patients with COVID-19
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 pneumonia patients | Patients treated at the University Hospital Osijek Respiratory Center with pneumonia caused by SARS-CoV-2 Receives: Diagnostic Test: Chest X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Jan 2020
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nenad Nešković, PhD, Principal investigator, University Hospital Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181696
- Sponsor's protocol ID
- OsijekUH-RC
- Acronym
- RANCH-COVID
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33661992Wolff 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.
PubMed 32860214Mahat 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.
PubMed 33778183Borghesi 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.
PubMed 32358689Borghesi 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.
PubMed 32358691
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Severity Scoring System and Clinical and Laboratory Evolution of COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05181696
- Acronym / sponsor ID
- RANCH-COVID / OsijekUH-RC
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 pneumonia patients | – | Diagnostic Test: Chest X-rayPatients treated at the University Hospital Osijek Respiratory Center with pneumonia caused by SARS-CoV-2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in ICU COVID-19 with a diagnosis of pneumonia will be analyzed retrospectively.
Key inclusion criteria (2 listed)
- Pneumonia caused by SARS-CoV-2 virus
- Admission to the ICU COVID-19 unit
Key exclusion criteria (1 listed)
- Patients with lung tumors or history of lung resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest X-rayRetrospective analysis of chest x-rays of patients with COVID-19 | Diagnostic test | COVID-19 pneumonia patients |
Primary outcome
Chest x-ray severity score
Time frame: 21 days
The influence of the dynamics of radiographic changes quantified by Brixia score on the outcome of COVID-19 patients will be examined
Inflammatory markers
Time frame: 21 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 33661992Booth 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.
- Background: PubMed 32860214Wolff 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.
- Background: PubMed 33778183Mahat 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.
- Background: PubMed 32358689Borghesi 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.
- Background: PubMed 32358691Borghesi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nenad Nešković, PhD principal investigator
University Hospital Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Sepsis, run by Osijek University Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nenad Nešković, PhD (+395996787250, nneskov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest x-ray severity score (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05181696, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.