Neuropathology in Adults Intensive Care Unit Patients With COVID 19

June 30, 2020 updated by: Djillali Annane, University of Versailles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients admitted to the ICU for severe COVID-19 and who died during their ICU stay and for whom family consent was obtained for performing autopsy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of severe acute respiratory syndrome related to coronavirus-2 in brain tissues
Time Frame: 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
From death up to five days
quantification of inflammation, necrosis and hemorrhage in different brain areas
Time Frame: 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.
From death up to five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Versailles

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

May 11, 2020

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obs2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

all individual patient data will be available upon request to the study official and after signing a data sharing agreement immediately after publication in a peer-reviewed journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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