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Neuropathology in Adults Intensive Care Unit Patients With COVID 19

A Prospective Observational Autopsy Study of Neuropathology in Adults Intensive Care Unit Patients With COVID 19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04453670
Enrollment
7
Registered
2020-07-01
Start date
2020-03-10
Completion date
2020-05-15
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Keywords

autopsy, coronavirus, brain, inflammation

Brief summary

This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses.

Detailed description

Setting: academic center designed as a referral center for patients with COVID-19 Design: single center observational autopsy study Participants: intensive care unit (ICU) adults who died from confirmed COVID-19 during the first wave of the pandemic in France. Oversight: As per legal health authority requirement only patients with suspected or confirmed severe acute respiratory syndrome (SARS)- related to coronavirus 2 infection were admitted to the ICU. The department of pathology and forensic medicine is allowed by legal authority to perform autopsy of non-survivors from COVID-19 to inform the cause of death as per ministerial decree of July 12 2017 and March 28, 2020. In this context, of autopsy for medical purpose and public interest there is no requirement for institutional review board submission. However, consent from patients legal representative or closest relatives is required for autopsy.

Interventions

PROCEDUREautopsy

autopsy

Sponsors

University of Versailles
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults * admitted to the ICU * confirmed COVID-19 * died during ICU stay

Exclusion criteria

* refusal from patient's legal representative or closest relative

Design outcomes

Primary

MeasureTime frameDescription
detection of severe acute respiratory syndrome related to coronavirus-2 in brain tissuesFrom death up to five daysSpecimens treatments Genome detection by real-time reverse transcriptase-polymerase chain reaction and viral culture Next generation sequencing Specimen RNA pre-treatment and evaluation MinION sequencing
quantification of inflammation, necrosis and hemorrhage in different brain areasFrom death up to five daysThe left hemisphere will be fixed in 10% buffered formalin. Multiple fresh samples will be acquired from different areas of the right hemisphere for freezing. For each frozen sample, a mirror sample of formalin-fixed paraffin-embedded tissue will be taken from the left hemisphere. Samples were fixed with 3.6% glutaraldehyde and embedded in plastic for electron microscopy. Paraffin sections cut to 3-µm thickness will be stained with hematoxylin and eosin stain. Immunohistochemistry will be performed with Clusters of Differentiation 3,4, 20, 68, 138, and glial fibrillary acid protein antibodies on automated immunostainer. Slides will be scanned and analyzed. Electron microscopy will be performed and images will be acquired.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026