Pneumonia, ViralNCT05290441
Evaluation of Postmortem Pulmonary Interstitial Fibrosis Severity and EGFR Positivity in Covid-19 Pneumonia
A study testing None involvement in people with Pneumonia, Viral and COVID-19 Pneumonia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the relationship between the severity of fibrosis in the lung tissue and EGFR positivity in patients who died due to covid-19 pneumonia, with the demographic characteristics, comorbidities, biochemistry values, treatments they received, and radiological appearances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Viral, COVID-19 Pneumonia, EGFR Amplification
- What is being tested?
- None involvement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 1 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- Patients who died while lying in the Intensive Care Unit with the diagnosis of Covid-19 pneumonia
Who cannot join
- <18 years old
- Patients who were treated with the diagnosis of Covid 19 pneumonia and recovered
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bursa Yüksek İhtisas EAH
Bursa, Eyalet/Yerleşke, 16115
Seyhan Dülger
Bursa, Yıldırım, 16115
About this study
The aim of this study is to examine the relationship between the severity of fibrosis in the lung tissue and EGFR positivity in patients who died due to covid-19 pneumonia, with the demographic characteristics, comorbidities, biochemistry values, treatments they received, and radiological appearances. Transthoracic tru-cut biopsy will be performed on patients who have died in the intensive care unit with the diagnosis of Covid 19 pneumonia. EGFR positivity will be evaluated in the material taken. The relationship between the severity of fibrosis and the demographic data of the patients, the drugs used and their radiological appearances will be analyzed statistically.
Read the detailed description
The pathophysiology of Covid 19 infection still remains complex. Diffuse alveolo-interstitial damage, organizing pneumonia and severe fibrotic organizing pneumonia have been reported and possibly associated with cytokine storm. However, profibrotic pathways and mediators involved in fibrosis and the severity of fibrosis may differ individually. Epidermal growth factor (EGF) is a protein-structured growth factor that stimulates cell division, differentiation, survival, proliferation, growth and cell migration. It acts through the epidermal growth factor receptor (EGFR). The stimulating effect of fibroblasts, kerotinocytes, and vascular endothelial cells is known to stimulate growth and proliferation, and plays a role in the repair process of the lungs and the development of pulmonary fibrosis. EGFR is also a tyrosine kinase receptor. The relationship between fibrosis severity and EGFR positivity in the tissues of deceased covid pneumonia patients, demographic data of the patients, their combinations and the treatment they receive may guide treatment approaches.
The aim of this study is to examine the relationship between the severity of fibrosis in the lung tissue and EGFR positivity in patients who died due to covid-19 pneumonia, demographic characteristics, comorbidities, biochemistry values, and treatments they receive.
Material methods: Transthoracic tru-cut biopsy will be performed with the permission of their families, for patients hospitalized in the intensive care unit of our hospital and who died due to Covid 19 pneumonia. Biopsy, where the involvement is more intense compared hemithorax to the radiological appearance, will be performed blindly. By studying EGFR on biopsy materials, fibrosis grade will be classified as 0=none; 1=mild; 2=medium; 3=severe. Thoracic CT images of the patients were reviewed by a radiologist, and the fibrosis image and extent will again be classified as 0=none; 1=mild; 2=medium; 3=severe. Medications used, additional diseases, demographic data, length of stay in the intensive care unit, and intubation times will be recorded. The relationship between EGFR positivity and other data will be analyzed statistically.
The relationship between fibrosis severity and EGFR positivity in the tissues of deceased covid pneumonia patients, demographic data of the patients, their combinations and the treatment they receive may guide treatment approaches. It may shed light on the fact that fibrolytic drugs, which act as tyrosine kinase inhibitors and are used in idiopathic interstitial fibrosis, can also be used in covid 19 pneumonia damage.
- Conditions
- Pneumonia, Viral, COVID-19 Pneumonia, EGFR Amplification
- Being tested
- None involvement
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None involvementProcedure or surgery
No EGFR involvement
| Study group | Role | What they receive |
|---|---|---|
| None involement | Active comparator | In the pathological examination, the group of patients without EGFR involvement in the biopsy material. Receives: Procedure: None involvement |
| Mild | Active comparator | In the pathological examination, the group of patients mild EGFR involvement in the biopsy material. Receives: Procedure: None involvement |
| Moderate | Active comparator | In the pathological examination, the group of patients moderate EGFR involvement in the biopsy material. Receives: Procedure: None involvement |
| Severe | Active comparator | In the pathological examination, the group of patients severe EGFR involvement in the biopsy material Receives: Procedure: None involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis
EGFR involvement
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Aug 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- cross-sectional interventional clinical research
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyhan Dülger,MD, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290441
- Sponsor's protocol ID
- 2011-KAEK-25 2021/08-10
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu X, Wang P, Zhang C, Ma Z. Epidermal growth factor receptor (EGFR): A rising star in the era of precision medicine of lung cancer. Oncotarget. 2017 Jul 25;8(30):50209-50220. doi: 10.18632/oncotarget.16854.
PubMed 28430586George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
PubMed 32422178Dulger SU, Mutlu N, Ceylan I, Ozhan E. The relationship between lung fibrosis, the epidermal growth factor receptor, and disease outcomes in COVID-19 pneumonia: a postmortem evaluation. Clin Exp Med. 2023 Aug;23(4):1181-1188. doi: 10.1007/s10238-022-00872-7. Epub 2022 Aug 20.
PubMed 35986823
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postmortem Pulmonary Interstitial Fibrosis Severity and EGFR Positivity in Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05290441
- Acronym / sponsor ID
- 2011-KAEK-25 2021/08-10
- Conditions
- Pneumonia, Viral, COVID-19 Pneumonia, EGFR Amplification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 22 Mar 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 aim of this study is to examine the relationship between the severity of fibrosis in the lung tissue and EGFR positivity in patients who died due to covid-19 pneumonia, with the demographic characteristics, comorbidities, biochemistry values, treatments they received, and radiological appearances. Transthoracic tru-cut biopsy will be performed on patients who have died in the intensive care unit with the diagnosis of Covid 19 pneumonia. EGFR positivity will be evaluated in the material taken. The relationship between the severity of fibrosis and the demographic data of the patients, the drugs used and their radiological appearances will be analyzed statistically.
Detailed description
The pathophysiology of Covid 19 infection still remains complex. Diffuse alveolo-interstitial damage, organizing pneumonia and severe fibrotic organizing pneumonia have been reported and possibly associated with cytokine storm. However, profibrotic pathways and mediators involved in fibrosis and the severity of fibrosis may differ individually. Epidermal growth factor (EGF) is a protein-structured growth factor that stimulates cell division, differentiation, survival, proliferation, growth and cell migration. It acts through the epidermal growth factor receptor (EGFR). The stimulating effect of fibroblasts, kerotinocytes, and vascular endothelial cells is known to stimulate growth and proliferation, and plays a role in the repair process of the lungs and the development of pulmonary fibrosis. EGFR is also a tyrosine kinase receptor. The relationship between fibrosis severity and EGFR positivity in the tissues of deceased covid pneumonia patients, demographic data of the patients, their combinations and the treatment they receive may guide treatment approaches.
The aim of this study is to examine the relationship between the severity of fibrosis in the lung tissue and EGFR positivity in patients who died due to covid-19 pneumonia, demographic characteristics, comorbidities, biochemistry values, and treatments they receive.
Material methods: Transthoracic tru-cut biopsy will be performed with the permission of their families, for patients hospitalized in the intensive care unit of our hospital and who died due to Covid 19 pneumonia. Biopsy, where the involvement is more intense compared hemithorax to the radiological appearance, will be performed blindly. By studying EGFR on biopsy materials, fibrosis grade will be classified as 0=none; 1=mild; 2=medium; 3=severe. Thoracic CT images of the patients were reviewed by a radiologist, and the fibrosis image and extent will again be classified as 0=none; 1=mild; 2=medium; 3=severe. Medications used, additional diseases, demographic data, length of stay in the intensive care unit, and intubation times will be recorded. The relationship between EGFR positivity and other data will be analyzed statistically.
The relationship between fibrosis severity and EGFR positivity in the tissues of deceased covid pneumonia patients, demographic data of the patients, their combinations and the treatment they receive may guide treatment approaches. It may shed light on the fact that fibrolytic drugs, which act as tyrosine kinase inhibitors and are used in idiopathic interstitial fibrosis, can also be used in covid 19 pneumonia damage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- cross-sectional interventional clinical research
| Arm | Type | Receives |
|---|---|---|
| None involement | Active comparator | Procedure: None involvementIn the pathological examination, the group of patients without EGFR involvement in the biopsy material. |
| Mild | Active comparator | Procedure: None involvementIn the pathological examination, the group of patients mild EGFR involvement in the biopsy material. |
| Moderate | Active comparator | Procedure: None involvementIn the pathological examination, the group of patients moderate EGFR involvement in the biopsy material. |
| Severe | Active comparator | Procedure: None involvementIn the pathological examination, the group of patients severe EGFR involvement in the biopsy material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years old
- Patients who died while lying in the Intensive Care Unit with the diagnosis of Covid-19 pneumonia
Key exclusion criteria (2 listed)
- <18 years old
- Patients who were treated with the diagnosis of Covid 19 pneumonia and recovered
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 |
|---|---|---|
| None involvementNo EGFR involvement | Procedure or surgery | Mild, Moderate, None involement, Severe |
Primary outcome
Fibrosis
Time frame: "through study completion, an average of 1 year".
EGFR involvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 28430586Liu X, Wang P, Zhang C, Ma Z. Epidermal growth factor receptor (EGFR): A rising star in the era of precision medicine of lung cancer. Oncotarget. 2017 Jul 25;8(30):50209-50220. doi: 10.18632/oncotarget.16854.
- Background: PubMed 32422178George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
- Derived from this study: PubMed 35986823Dulger SU, Mutlu N, Ceylan I, Ozhan E. The relationship between lung fibrosis, the epidermal growth factor receptor, and disease outcomes in COVID-19 pneumonia: a postmortem evaluation. Clin Exp Med. 2023 Aug;23(4):1181-1188. doi: 10.1007/s10238-022-00872-7. Epub 2022 Aug 20.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing None involvement in people with Pneumonia, Viral and COVID-19 Pneumonia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis (time frame: "through study completion, an average of 1 year".). 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 NCT05290441, which also lists 3 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 6 Feb 2025.