Study of the Sars-Cov2 Neuroinvasiveness - COVID19

NCT ID: NCT04427254

Last Updated: 2023-07-11

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

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-26

Study Completion Date

2022-11-25

Brief Summary

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Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.

Detailed Description

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Conditions

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COVID19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neurological biological samples

Group Type EXPERIMENTAL

Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

Intervention Type DRUG

Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

Interventions

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Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery

Exclusion Criteria

* Pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre BOURDILLON, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation A. de Rothschild

Locations

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Fondation A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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PBN_2020_16

Identifier Type: -

Identifier Source: org_study_id

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