- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427254
Study of the Sars-Cov2 Neuroinvasiveness - COVID19 (CORONEVRAXE)
July 10, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
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
-
-
-
Paris, France, 75019
- Fondation A De Rothschild
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery
Exclusion Criteria:
- Pregnant or lactating women
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurological biological samples
|
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with COVID-19 positive samples/biopsies
Time Frame: At the time of the inclusion
|
COVID-19 RT-PCR test
|
At the time of the inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pierre Bourdillon, MD, Fondation A. de Rothschild
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)
June 26, 2020
Primary Completion (Actual)
November 25, 2022
Study Completion (Actual)
November 25, 2022
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBN_2020_16
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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