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Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568707
Recruitment Status : Not yet recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborator:
Brain & Spine Institute (ICM)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Covid19 Neurologic Manifestations Psychiatric Manifestations Other: blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Covid-19 infection
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
blood sample for serum (serology, biomarkers) and DNA




Primary Outcome Measures :
  1. dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients [ Time Frame: 12 months ]
    dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients


Secondary Outcome Measures :
  1. Serum neurofilaments [ Time Frame: 12 months ]
    Neurodegenerative markers (e.g., neurofilaments) associated with a neurological or psychiatric manifestation of Covid-19 infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568707


Contacts
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Contact: Céline LOUAPRE, MD 1 42 16 57 66 ext +33 celine.louapre@aphp.fr
Contact: Jean-Christophe CORVOL, MD,PHD 1 42 16 57 66 ext +33 jean-christophe.corvol@aphp.fr

Locations
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France
Hôpital Pitié Salpétrière
Paris, France, 75013
Contact: Céline LOUAPRE, MD    1 42 16 57 66 ext +33    celine.louapre@aphp.fr   
Principal Investigator: Céline LOUAPRE, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Brain & Spine Institute (ICM)
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04568707    
Other Study ID Numbers: APHP200845
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19
neurological disease
Multiple Sclerosis
psychiatric disease
biology,
biocollection,
biomarkers,
DNA,
Parkinson's Disease
Additional relevant MeSH terms:
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Nervous System Diseases
Neurologic Manifestations