Neuropathology in Adults Intensive Care Unit Patients With COVID 19

Sponsor

University of Versailles (Other)

Overall Status

Completed

CT.gov ID

NCT04453670

Collaborator

(none)

Enrollment

Location

2.2

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID 19	Procedure: autopsy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

7 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 10, 2020

Actual Primary Completion Date :

May 11, 2020

Actual Study Completion Date :

May 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 non-survivors ICU adults who died from severe COVID-19 and in whom autopsy could be performed	Procedure: autopsy autopsy

Arm

Intervention/Treatment

COVID-19 non-survivors

ICU adults who died from severe COVID-19 and in whom autopsy could be performed

Procedure: autopsy

autopsy

Outcome Measures

Primary Outcome Measures

detection of severe acute respiratory syndrome related to coronavirus-2 in brain tissues [From death up to five days]
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
quantification of inflammation, necrosis and hemorrhage in different brain areas [From death up to five days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Raymond Poincaré	Garches		France	92380

Sponsors and Collaborators

University of Versailles

Investigators

Study Chair: djillali annane, University Versailles SQY Unversité Paris Saclay

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Djillali Annane, Professor in intensive care medicine, University of Versailles

ClinicalTrials.gov Identifier:

NCT04453670

Other Study ID Numbers:

Obs2020

First Posted:

Jul 1, 2020

Last Update Posted:

Jul 1, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Djillali Annane, Professor in intensive care medicine, University of Versailles

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 1, 2020