Back to resultsEvaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)
Primary Purpose
Covid19, Neurologic Manifestations, Psychiatric Manifestations
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Covid19 focused on measuring COVID-19, neurological disease, Multiple Sclerosis, psychiatric disease, biology,, biocollection,, biomarkers,, DNA,, Parkinson's Disease
Eligibility Criteria
- Age over 18 yo
- Patient having presented or presenting a Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
And patient with:
- a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or
- either a chronic neurological or psychiatric pathology
Sites / Locations
- Hôpital Pitié SalpétrièreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Covid-19 infection
Arm Description
Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
Outcomes
Primary Outcome Measures
dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients
dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients
Secondary Outcome Measures
Serum neurofilaments
Neurodegenerative markers (e.g., neurofilaments) associated with a neurological or psychiatric manifestation of Covid-19 infection
Full Information
NCT ID
NCT04568707
First Posted
August 31, 2020
Last Updated
February 24, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Brain & Spine Institute (ICM)
1. Study Identification
Unique Protocol Identification Number
NCT04568707
Brief Title
Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)
Official Title
Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Brain & Spine Institute (ICM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Neurologic Manifestations, Psychiatric Manifestations
Keywords
COVID-19, neurological disease, Multiple Sclerosis, psychiatric disease, biology,, biocollection,, biomarkers,, DNA,, Parkinson's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Covid-19 infection
Arm Type
Experimental
Arm Description
Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
blood sample for serum (serology, biomarkers) and DNA
Primary Outcome Measure Information:
Title
dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients
Description
dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Serum neurofilaments
Description
Neurodegenerative markers (e.g., neurofilaments) associated with a neurological or psychiatric manifestation of Covid-19 infection
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Age over 18 yo
Patient having presented or presenting a Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
And patient with:
a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or
either a chronic neurological or psychiatric pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline LOUAPRE, MD
Phone
1 42 16 57 66
Ext
+33
Email
celine.louapre@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe CORVOL, MD,PHD
Phone
1 42 16 57 66
Ext
+33
Email
jean-christophe.corvol@aphp.fr
Facility Information:
Facility Name
Hôpital Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline LOUAPRE, MD
Phone
1 42 16 57 66
Ext
+33
Email
celine.louapre@aphp.fr
First Name & Middle Initial & Last Name & Degree
Céline LOUAPRE, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34341142
Citation
Louapre C, Ibrahim M, Maillart E, Abdi B, Papeix C, Stankoff B, Dubessy AL, Bensa-Koscher C, Creange A, Chamekh Z, Lubetzki C, Marcelin AG, Corvol JC, Pourcher V; COVISEP and Bio-coco-neuroscience study group. Anti-CD20 therapies decrease humoral immune response to SARS-CoV-2 in patients with multiple sclerosis or neuromyelitis optica spectrum disorders. J Neurol Neurosurg Psychiatry. 2022 Jan;93(1):24-31. doi: 10.1136/jnnp-2021-326904. Epub 2021 Aug 2.
Results Reference
derived
Learn more about this trial
Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)
We'll reach out to this number within 24 hrs