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

February 1, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hôpital Pitié Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Brain & Spine Institute (ICM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200845

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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