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临床试验/NCT04678687
NCT04678687Unknown不适用

Evaluation of Postmortem Biopsy Specimens of COVID-19 Cases

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
The level of histopathological changes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The level of histopathological changes

时间窗: in three months after the participant's death

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Nuri Yakar

MD, PhD, Research Assistant

Dokuz Eylul University

研究点 (2)

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