Covid19NCT04678687
COVID-19 and Tissue Damage in Vital Organs
A study testing Liver, lung, heart and kidney biopsy in people with Covid19 and Postmortem Changes, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Postmortem Changes
- What is being tested?
- Liver, lung, heart and kidney biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postmortem Biopsy Specimens of COVID-19 Cases
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:
- Cases whose treatment process resulted in death will be included in the study.
- The cases must be confirmed with the diagnosis of COVID-19 by the RT-PCR (real time polymerase chain reaction) test.
- The first-degree relatives must consent for the participation of the subjects in the study by their first-degree relatives.
Read more
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.
- Conditions
- Covid19, Postmortem Changes
- Being tested
- Liver, lung, heart and kidney biopsy
- Medical subject headings
- COVID-19, Postmortem Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver, lung, heart and kidney biopsyProcedure or surgery
Liver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | Other | Liver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group. Receives: Procedure: Liver, lung, heart and kidney biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: in three months after the participant's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Nuri Yakar, Dokuz Eylul University
- Investigators
- Ali N Gökmen, MD, PhD, Principal investigator, Dokuz Eylul University, Department of Anaesthesiology and Reanimation, Division of Intensive CareMehmet N Yakar, MD, PhD, Study director, Dokuz Eylul University, Department of Anaesthesiology and Reanimation, Division of Intensive CareSafiye Aktaş, MD, PhD, Study director, Dokuz Eylul University, Oncology Institute, Department of Basic OncologyBilgin Cömert, MD, PhD, Study director, Dokuz Eylul University, Department of Internal Medicine, Division of Intensive CareBegüm Ergan, MD, PhD, Study director, Dokuz Eylul University, Department of Chest Disease, Division of Intensive CareBişar Ergün, MD, PhD, Study director, Dokuz Eylul University, Department of Internal Medicine, Division of Intensive CareFırat Bayraktar, MD, PhD, Study chair, Dokuz Eylul University, Department of Internal Medicine, Division of Endocrinology and MetabolismEyüp S Uçan, MD, PhD, Study chair, Dokuz Eylul University, Department of Chest Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678687
- Sponsor's protocol ID
- COVID-19.PMB
- Status last verified
- Feb 2021
- First submitted
- 2 Dec 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postmortem Biopsy Specimens of COVID-19 Cases
- ClinicalTrials.gov ID
- NCT04678687
- Acronym / sponsor ID
- COVID-19.PMB
- Conditions
- Covid19, Postmortem Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Cases whose treatment process resulted in death will be included in the study.
- The cases must be confirmed with the diagnosis of COVID-19 by the RT-PCR (real time polymerase chain reaction) test.
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | Other | Procedure: Liver, lung, heart and kidney biopsyLiver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver, lung, heart and kidney biopsyLiver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group. | Procedure or surgery | COVID-19 group |
Primary outcome
The level of histopathological changes
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver, lung, heart and kidney biopsy in people with Covid19 and Postmortem Changes, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of histopathological changes (time frame: in three months after the participant's death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.