COVID19CORONEVRAXENCT04427254
Study of the Sars-Cov2 Neuroinvasiveness - COVID19
A study testing Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies in people with COVID19, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2020to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery
Who cannot join
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COVID19
- Being tested
- Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
- Keywords
- Sars-Cov2 neuroinvasiveness, COVID-19 RT-PCR test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsiesDrug
Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
| Study group | Role | What they receive |
|---|---|---|
| Neurological biological samples | Experimental | Not described Receives: Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with COVID-19 positive samples/biopsies
COVID-19 RT-PCR test
Measured: At the time of the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start26 Jun 2020
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Why it stopped: enrollment number not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre BOURDILLON, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427254
- Sponsor's protocol ID
- PBN_2020_16
- Acronym
- CORONEVRAXE
- Status last verified
- Jul 2023
- First submitted
- 26 May 2020
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Sars-Cov2 Neuroinvasiveness - COVID19
- ClinicalTrials.gov ID
- NCT04427254
- Acronym / sponsor ID
- CORONEVRAXE / PBN_2020_16
- Conditions
- COVID19
- Keywords
- Sars-Cov2 neuroinvasiveness, COVID-19 RT-PCR test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment number not reached
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurological biological samples | Experimental | Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery
Key exclusion criteria (1 listed)
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsiesCerebrospinal fluid sampling, meningeal and brain parenchyma biopsies | Drug | Neurological biological samples |
Primary outcome
Percentage of patients with COVID-19 positive samples/biopsies
Time frame: At the time of the inclusion
COVID-19 RT-PCR test
Results and safety
The study was stopped early (reason given: enrollment number not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre BOURDILLON, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies in people with COVID19, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment number not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with COVID-19 positive samples/biopsies (time frame: At the time of the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.