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CompletedNCT05290441Updated Feb 6, 2025

Evaluation of Postmortem Pulmonary Interstitial Fibrosis Severity and EGFR Positivity in Covid-19 Pneumonia

An interventional study of None involvement in Pneumonia, Viral, COVID-19 Pneumonia and EGFR Amplification, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 2 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pneumonia, Viral
  • COVID-19 Pneumonia
  • EGFR Amplification

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03

In context

Pneumonia, Viral

156 studies on the registry are indexed under Pneumonia, Viral; 13 are open to participants now.

This study's enrollment of 65 is below the median of 76 across 88 interventional studies indexed under Pneumonia, Viral.

Browse Pneumonia, Viral studies →

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 18 years old
  • Patients who died while lying in the Intensive Care Unit with the diagnosis of Covid-19 pneumonia

Exclusion criteria

Exclusion Criteria:

  • \<18 years old
  • Patients who were treated with the diagnosis of Covid 19 pneumonia and recovered
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    None involement

    In the pathological examination, the group of patients without EGFR involvement in the biopsy material.

    Procedure: None involvement

  • Active comparator
    Mild

    In the pathological examination, the group of patients mild EGFR involvement in the biopsy material.

    Procedure: None involvement

  • Active comparator
    Moderate

    In the pathological examination, the group of patients moderate EGFR involvement in the biopsy material.

    Procedure: None involvement

  • Active comparator
    Severe

    In the pathological examination, the group of patients severe EGFR involvement in the biopsy material

    Procedure: None involvement

Interventions

  • ProcedureNone involvement

    No EGFR involvement

06

What researchers measure

Primary outcomes

  1. Fibrosis

    EGFR involvement

    Time frame: "through study completion, an average of 1 year".

07

Study locations

2 sites
  • Bursa Yüksek İhtisas EAH
    Bursa, Eyalet/Yerleşke 16115, Turkey
  • Seyhan Dülger
    Bursa, Yıldırım 16115, Turkey
08

References and documents

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 28430586 ↗
  • George 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 32422178 ↗
  • Dulger 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05290441
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Seyhan Dülger,MD (associate professor, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Mar 22, 2022
Start date
Aug 15, 2021
Primary completion
Dec 1, 2021
Completion
Dec 1, 2022
Last update
Feb 6, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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