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Study of the Sars-Cov2 Neuroinvasiveness - COVID19 (CORONEVRAXE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427254
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID19 Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Sars-Cov2 Neuroinvasiveness - COVID19
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Neurological biological samples Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies




Primary Outcome Measures :
  1. Percentage of patients with COVID-19 positive samples/biopsies [ Time Frame: At the time of the inclusion ]
    COVID-19 RT-PCR test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427254


Contacts
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Contact: Amélie YAVCHITZ, MD (0)148036454 ext +33 ayavchitz@for.paris

Locations
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France
Fondation A de Rothschild
Paris, France, 75019
Contact: Pierre BOURDILLON, MD    (0)1 48 03 68 22 ext +33    pbourdillon@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Pierre BOURDILLON, MD Fondation A. de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04427254    
Other Study ID Numbers: PBN_2020_16
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Sars-Cov2 neuroinvasiveness
COVID-19 RT-PCR test