NCT04568707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

August 31, 2020

Last Update Submit

February 1, 2024

Conditions

Covid19Neurologic ManifestationsPsychiatric Manifestations

Keywords

COVID-19neurological diseaseMultiple Sclerosispsychiatric diseasebiology,biocollection,biomarkers,DNA,Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (1)

  • Serum neurofilaments

    12 months

Study Arms (1)

Covid-19 infection

EXPERIMENTAL

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

Other: blood sample

Interventions

blood sampleOTHER

blood sample for serum (serology, biomarkers) and DNA

Covid-19 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
1. Age over 18 yo 2. 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 3. And patient with: 1. a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or 2. either a chronic neurological or psychiatric pathology

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pitié Salpétrière

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 34341142DERIVED

MeSH Terms

Conditions

COVID-19Neurologic ManifestationsNervous System DiseasesMultiple SclerosisMental DisordersParkinson Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 29, 2020

Study Start

October 23, 2020

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

February 2, 2024

Record last verified: 2024-02

Locations

FR(1)