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NCT04568707 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04568707
Other study ID # APHP200845
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2020
Est. completion date December 14, 2022

Study information
Verified date February 2024
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 238
Est. completion date December 14, 2022
Est. primary completion date December 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• blood sample
blood sample for serum (serology, biomarkers) and DNA

Locations
Country Name City State
France Hôpital Pitié Salpétrière Paris

Sponsors (2)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Brain & Spine Institute (ICM)

Country where clinical trial is conducted

France, 

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