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

NCT ID: NCT05290441

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2022-12-01

Brief Summary

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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

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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

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Pneumonia, Viral COVID-19 Pneumonia EGFR Amplification

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

cross-sectional interventional clinical research
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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None involement

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

Group Type ACTIVE_COMPARATOR

None involvement

Intervention Type PROCEDURE

No EGFR involvement

Mild

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

Group Type ACTIVE_COMPARATOR

None involvement

Intervention Type PROCEDURE

No EGFR involvement

Moderate

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

Group Type ACTIVE_COMPARATOR

None involvement

Intervention Type PROCEDURE

No EGFR involvement

Severe

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

Group Type ACTIVE_COMPARATOR

None involvement

Intervention Type PROCEDURE

No EGFR involvement

Interventions

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None involvement

No EGFR involvement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \<18 years old
* Patients who were treated with the diagnosis of Covid 19 pneumonia and recovered
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Seyhan Dülger,MD

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bursa Yüksek İhtisas EAH

Bursa, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Seyhan Dülger

Bursa, Yıldırım, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28430586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32422178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35986823 (View on PubMed)

Other Identifiers

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2011-KAEK-25 2021/08-10

Identifier Type: -

Identifier Source: org_study_id

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