NCT05290441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 6, 2025

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

January 13, 2022

Last Update Submit

February 4, 2025

Conditions

Pneumonia, ViralCOVID-19 PneumoniaEGFR Amplification

Outcome Measures

Primary Outcomes (1)

  • Fibrosis

    EGFR involvement

    "through study completion, an average of 1 year".

Study Arms (4)

None involement

ACTIVE COMPARATOR

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

Procedure: None involvement

Mild

ACTIVE COMPARATOR

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

Procedure: None involvement

Moderate

ACTIVE COMPARATOR

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

Procedure: None involvement

Severe

ACTIVE COMPARATOR

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

Procedure: None involvement

Interventions

None involvementPROCEDURE

No EGFR involvement

MildModerateNone involementSevere

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bursa Yüksek İhtisas EAH

Bursa, Eyalet/Yerleşke, 16115, Turkey (Türkiye)

Location

Seyhan Dülger

Bursa, Yıldırım, 16115, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28430586BACKGROUND

  • 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.

    PMID: 32422178BACKGROUND

  • 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.

    PMID: 35986823DERIVED

MeSH Terms

Conditions

Pneumonia, Viral

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: cross-sectional interventional clinical research
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 13, 2022

First Posted

March 22, 2022

Study Start

August 15, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

February 6, 2025

Record last verified: 2022-03

Locations

TU(2)