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

NCT04366882 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-08-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hasselt University

    collaborator OTHER

  • University Hospital, Antwerp

    collaborator OTHER

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Janneke Cox, MD, PhD · Jessa Hospital

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2020-12-31
Completion
2023-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366882 on ClinicalTrials.gov