Neuropathology in Adults Intensive Care Unit Patients With COVID 19

COVID 19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453670
• Other study ID #: Obs2020
• Status: Completed
• Start date: March 10, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: June 2020
• Source: University of Versailles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 15, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19

Intervention

Procedure:
• autopsy
autopsy

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
University of Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of severe acute respiratory syndrome related to coronavirus-2 in brain tissues	Specimens 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	From death up to five days
Primary	quantification of inflammation, necrosis and hemorrhage in different brain areas	The 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.	From death up to five days