Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients (MIA-COVID-19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04366882|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : August 9, 2022
Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemic with high morbidity and mortality. The main cause of death is respiratory failure including acute respiratory distress syndrome, however the exact mechanisms and other underlying pathology is currently not yet known. In the current setting of the COVID-19 pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission. Yet, as so little is known, additional histopathological, microbiological and virologic study of tissue of deceased COVID-19 patients will provide important clinical and pathophysiological information. Minimal invasive autopsy combined with postmortem imaging seems therefore an optimal method combining safety on the one hand yet proving significant information on the other.
This study aims to determine the cause of death and attributable conditions in deceased COVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guided MIA to obtain tissue for further histological, microbiological and pathological diagnostics. In addition, the pathophysiology of COVID-19 will be examined by further tissue analysis.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Procedure: CT-scan with minimal invasive autopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Increasing Our Understanding of COVID-19: Minimal Invasive Autopsies to Investigate Clinical, Radiological, Microbiological and Histopathological Changes in Deceased COVID-19 Patients|
|Actual Study Start Date :||April 14, 2020|
|Actual Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 2023|
- Procedure: CT-scan with minimal invasive autopsy
CT-guided biopsies will be performed directly following the diagnostic CT-scan. Biopsies will be taken from heart, liver, lungs, spleen, kidneys and abdominal fat according to a standard operation procedure. Biopsies will be taken for further histological examination and storage in the biobank. Of the lung, additional samples will be taken for microbiological examination. Additional samples will be taken in case of (focal) abnormalities on CT-imaging. In case of pleural, cardiac or abdominal fluid, this will be aspirated for further cytological, biochemical and microbiological examination. Finally, 15 cc blood will be drawn from the heart.
- Determination of cause of death and contributing factors based on clinical, radiological, microbiological and histopathological data of the deceased patient [ Time Frame: up to one month ]
For each individual patient the cause of death and contributing factors will be assessed. For each individual these diagnoses will be made during a meeting of a multidisciplinary team consisting of at least an infectious diseases physician, a radiologist and a pathologist. On a case to case basis, additional medical specialists can be asked to attend, including an intensive care specialist, a geriatrician and/or a microbiologist.
During the meetings, the clinical, radiological, microbiological and histopathological data will be presented to all attending specialists. The final diagnoses will be based on consensus.
Outcomes will be reported as proportions with a 95% confidence interval.
- Detailed description of the postmortem radiological changes induced by COVID-19 [ Time Frame: up to one month ]The radiological findings will be systematically scored as absent or present. These findings will be reported as proportions with a 95% confidence interval.
- Detailed description of the postmortem histopathological changes induced by COVID-19 [ Time Frame: up to one month ]On the basis of clinical observations at this moment in time correlations will be done between the renal histology findings of the patients with and without renal failure at death as well as between the cardiac histology findings of the patients with and without clinical signs of myocarditis. However, in the light of continuous clinical observations and new insights, this may be expanded in the future. Outcomes will be reported as proportions with a 95% confidence interval.
- Postmortem quantity of viral RNA [ Time Frame: up to one month ]Describe the quantity of viral RNA in the different tissues and relate this to the clinical, radiological and histopathological findings.
- Postmortem disease mechanisms at cellular level [ Time Frame: up to one month ]Study in detail the disease mechanisms at cellular level (including ACE-2 receptor expression in relation to quantity of viral RNA) in the different tissues.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366882
|Principal Investigator:||Janneke Cox, MD, PhD||Jessa Hospital|