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

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05290441
Collaborator
(none)
65
2
4
6.5
32.5
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: None involvement
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
cross-sectional interventional clinical researchcross-sectional interventional clinical research
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Postmortem Pulmonary Interstitial Fibrosis Severity and EGFR Positivity in Covid-19 Pneumonia
Actual Study Start Date :
Aug 15, 2021
Actual Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fibrosis ["through study completion, an average of 1 year".]

    EGFR involvement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Yüksek İhtisas EAH Bursa Eyalet/Yerleşke Turkey 16115
2 Seyhan Dülger Bursa Yıldırım Turkey 16115

Sponsors and Collaborators

  • Bursa Yüksek İhtisas Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Seyhan Dülger,MD, associate professor, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05290441
Other Study ID Numbers:
  • 2011-KAEK-25 2021/08-10
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022