Neuropathology in Adults Intensive Care Unit Patients With COVID 19

NCT ID: NCT04453670

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-05-15

Brief Summary

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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

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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.

Conditions

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COVID 19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 non-survivors

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

autopsy

Intervention Type PROCEDURE

autopsy

Interventions

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autopsy

autopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Versailles

OTHER

Sponsor Role lead

Responsible Party

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Djillali Annane

Professor in intensive care medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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djillali annane

Role: STUDY_CHAIR

University Versailles SQY Unversité Paris Saclay

Locations

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Hôpital Raymond Poincaré

Garches, , France

Site Status

Countries

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France

Other Identifiers

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Obs2020

Identifier Type: -

Identifier Source: org_study_id

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