Back to resultsStudy of the Sars-Cov2 Neuroinvasiveness - COVID19 (CORONEVRAXE)
Primary Purpose
COVID19
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
Sponsored by
About this trial
This is an interventional other trial for COVID19 focused on measuring Sars-Cov2 neuroinvasiveness, COVID-19 RT-PCR test
Eligibility 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
Sites / Locations
- Fondation A de Rothschild
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurological biological samples
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with COVID-19 positive samples/biopsies
COVID-19 RT-PCR test
Secondary Outcome Measures
Full Information
NCT ID
NCT04427254
First Posted
May 26, 2020
Last Updated
July 10, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT04427254
Brief Title
Study of the Sars-Cov2 Neuroinvasiveness - COVID19
Acronym
CORONEVRAXE
Official Title
Study of the Sars-Cov2 Neuroinvasiveness - COVID19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
enrollment number not reached
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
November 25, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
Keywords
Sars-Cov2 neuroinvasiveness, COVID-19 RT-PCR test
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurological biological samples
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
Intervention Description
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
Primary Outcome Measure Information:
Title
Percentage of patients with COVID-19 positive samples/biopsies
Description
COVID-19 RT-PCR test
Time Frame
At the time of the inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre BOURDILLON, MD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Sars-Cov2 Neuroinvasiveness - COVID19
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