CORONEVRAXE: Study of the Sars-Cov2 Neuroinvasiveness - COVID19
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT04427254
Collaborator
(none)
500
1
1
30.2
16.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
Actual Study Start Date
:
Jun 26, 2020
Anticipated Primary Completion Date
:
Jan 1, 2023
Anticipated Study Completion Date
:
Jan 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neurological biological samples
|
Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with COVID-19 positive samples/biopsies [At the time of the inclusion]
COVID-19 RT-PCR test
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery
Exclusion Criteria:
- Pregnant or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondation A de Rothschild | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
- Principal Investigator: Pierre BOURDILLON, MD, Fondation A. de Rothschild
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT04427254
Other Study ID Numbers:
- PBN_2020_16
First Posted:
Jun 11, 2020
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
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
Additional relevant MeSH terms: