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

March 19, 2022 updated by: Seyhan Dülger,MD, Bursa Yüksek İhtisas Education and Research Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Bursa, Eyalet/Yerleşke, Turkey, 16115
        • Recruiting
        • Bursa Yuksek Ihtisas Eah
        • Contact:
    • Yıldırım
      • Bursa, Yıldırım, Turkey, 16115
        • Recruiting
        • Seyhan Dülger
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: None involement
In the pathological examination, the group of patients without EGFR involvement in the biopsy material.
Procedure: None involvement
No EGFR involvement
Active Comparator: Mild
In the pathological examination, the group of patients mild EGFR involvement in the biopsy material.
Procedure: None involvement
No EGFR involvement
Active Comparator: Moderate
In the pathological examination, the group of patients moderate EGFR involvement in the biopsy material.
Procedure: None involvement
No EGFR involvement
Active Comparator: Severe
In the pathological examination, the group of patients severe EGFR involvement in the biopsy material
Procedure: None involvement
No EGFR involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrosis
Time Frame: "through study completion, an average of 1 year".
EGFR involvement
"through study completion, an average of 1 year".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 19, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2021/08-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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