CClinicalTrials.gg
Status unknownNCT04678687Updated Feb 3, 2021

COVID-19 and Tissue Damage in Vital Organs

An interventional study of Liver, lung, heart and kidney biopsy in Covid19 and Postmortem Changes, sponsored by Dokuz Eylul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study will be conducted in Dokuz Eylül University Hospital, COVID-19 (Coronavirus Disease 2019) intensive care unit. Three primary conditions will be sought for participants:

  1. Cases whose treatment process resulted in death will be included in the study.
  2. The cases must be confirmed with the diagnosis of COVID-19 by the RT-PCR (real time polymerase chain reaction) test.
  3. The first-degree relatives must consent for the participation of the subjects in the study by their first-degree relatives.

In the study, samples will be taken from the liver, kidney, lung, and heart. The samples will be stored in a protective solution and sent to the pathology unit. The examinations will determine the microscopic damage to these organs caused by COVID-19.

Also, the presence of the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) will be investigated by RT-PCR in tissues. The presence of ACE-2 (angiotensin converting enzyme 2) receptor and SARS-CoV-2 nucleoprotein antibody will be investigated by histochemical examination in tissues.

Read the detailed description

The cases whose treatment resulted in death at Dokuz Eylül University Research and Application Hospital Anesthesiology Intensive Care Unit and whose COVID-19 diagnosis was confirmed by the RT-PCR (real time polymerase chain reaction) test and gave written consent to the inclusion of the patient in the study by a first-degree relative will be included in the study. In the study, samples will be taken from 10 cases in total.

Age, gender, length of hospital stay, respiratory rate at the time of hospitalization, oxygene saturation on ICU admission and Horwitz ratio on ICU admission will be recorded. Also, the comorbidities of these cases, the interpretation of the computed tomography findings performed at the first admission to the hospital in terms of COVID-19, the RT-PCR results routinely sent for COVID-19 examination will be recorded in the case report form. Besides, all medical and supportive treatments applied during the intensive care treatment will be recorded. Liver and kidney function tests, inflammation and coagulation markers, hemoglobin level , and cardiac markers, which are routinely examined at the patient's admission to the intensive care unit, will be recorded.

Postmortem biopsy samples will be performed within 1 hour after the diagnosis of death is confirmed by the patient's doctor. The researchers will perform the procedures in the isolated room prepared for interventional procedures in intensive care. Researchers will wear personal protective equipment (cap, mask, goggles, gloves) before the procedure under the Ministry of Health's instructions.

Biopsy specimens will be taken from the lung, liver, heart, and kidney. Heart, liver, and kidney biopsies were performed as a core biopsy with tru-cut needles under ultrasonography guidance; lung biopsy will be performed by passing through the airway using biopsy forceps.

Each of the biopsy samples will be placed separately in 10 ml of 10% phosphate-buffered formalin solution. The containers will be disinfected with 80% alcohol. It will be placed in a closed zippered bag and kept at room temperature. It will be delivered to the pathology unit after 24 hours. The procedures as tissue cassette, extended tissue tracing, paraffin blocking, sectioning, and hematoxylin-eosin staining will be performed under biosafety level 2 rules in pathology. The cases will be coded as CVDPM-1... (Coronavirus Disease Postmortem 1...). Case report forms will be shared with researchers who will conduct pathological examination over the internet. Informed consent forms received from patients' relatives will be filed in the COVID-19 Intensive Care Unit.

Routine pathology sections will be evaluated in light microscopy according to the following criteria.

Lungs; alveolar epithelial cell damage, hyaline membrane formation, type 2 pneumocyte hyperplasia, diffuse alveolar damage, fibroblastic proliferation, fibrin accumulation, inflammatory infiltration, and the nature of inflammation Liver; lobular lymphocyte infiltration, centrilobular sinusoidal dilatation Kidney; diffuse proximal tubule damage, brushed edge loss, non-isometric vacuolar degeneration, necrosis, hemosiderin, pigmented cast, capillary plugs, vasculitis, intercalary inflammation, hemorrhage, Heart; acute ischemic injury, vascular pathology, inflammation Tissues will be tested for the presence of the SARS-CoV-2 virus by RT-PCR test. ACE2 receptor and SARS-CoV-2 nucleoprotein antibody will be examined by immunohistochemistry.

02

Conditions studied

  • Covid19
  • Postmortem Changes

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 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

Inclusion criteria

  • Cases 18 years and older than 18 years.
  • Cases diagnosed with COVID-19 confirmed by PCR test.
  • Cases whose treatment resulted in death.
  • Cases that was allowed the participation in the study by signing the informed consent form by their first degree relatives.

Exclusion criteria

Exclusion Criteria:

  • Cases less than 18 years old.
  • Cases for which the diagnosis of COVID-19 could not be confirmed.
  • Cases for which informed consent could not be obtained.
  • Cases whose treatment continues or results in healing.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    COVID-19 group

    Liver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group.

    Procedure: Liver, lung, heart and kidney biopsy

Interventions

  • ProcedureLiver, lung, heart and kidney biopsy

    Liver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group.

06

What researchers measure

Primary outcomes

  1. The level of histopathological changes

    In lung; alveolar epithelial cell damage, hyaline membrane formation, type 2 pneumocyte hyperplasia, diffuse alveolar damage, fibroblastic proliferation, fibrin accumulation, inflammatory infiltration and the nature of inflammation. In liver; lobular lymphocytic infiltration, centrilobular sinusoidal dilatation. In kidney; diffuse proximal tubule damage, brushed edge loss, non-isometric vacuolar degeneration, necrosis, hemosiderin, pigment cast, capillary plugs, vasculitis, interciliary inflammation, hemorrhage. In heart; acute ischemic injury, vascular pathology, inflammation.

    Time frame: in three months after the participant's death

07

Study locations

1 site
  • Dokuz Eylul University
    İzmir, Balçova 35330, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04678687
Lead sponsor
Dokuz Eylul University
Responsible party
Mehmet Nuri Yakar (MD, PhD, Research Assistant, Dokuz Eylul University) — Principal investigator
First posted
Dec 22, 2020
Start date
Jan 1, 2021
Primary completion
Jun 1, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Feb 3, 2021

Study contacts

Ali N Gökmen, MD, PhD
principal investigator · Dokuz Eylul University, Department of Anaesthesiology and Reanimation, Division of Intensive Care
Mehmet N Yakar, MD, PhD
study director · Dokuz Eylul University, Department of Anaesthesiology and Reanimation, Division of Intensive Care
Safiye Aktaş, MD, PhD
study director · Dokuz Eylul University, Oncology Institute, Department of Basic Oncology
Bilgin Cömert, MD, PhD
study director · Dokuz Eylul University, Department of Internal Medicine, Division of Intensive Care
Begüm Ergan, MD, PhD
study director · Dokuz Eylul University, Department of Chest Disease, Division of Intensive Care
Bişar Ergün, MD, PhD
study director · Dokuz Eylul University, Department of Internal Medicine, Division of Intensive Care
Fırat Bayraktar, MD, PhD
study chair · Dokuz Eylul University, Department of Internal Medicine, Division of Endocrinology and Metabolism
Eyüp S Uçan, MD, PhD
study chair · Dokuz Eylul University, Department of Chest Disease
Aylin Erol
study chair · Dokuz Eylul University, Oncology Institute
Özde E Gökbayrak
study chair · Dokuz Eylul University, Oncology Institute

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion