NCT04366882

Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients

Increasing Our Understanding of COVID-19: Minimal Invasive Autopsies to Investigate Clinical, Radiological, Microbiological and Histopathological Changes in Deceased COVID-19 Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-12-31
• Completion: 2023-12-01
• First posted: 2020-04-29
• Last updated: 2022-08-09

Locations

1 site across 1 country: Belgium