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Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders (CoCo-Neurosciences) (CoCo-Neuro)

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: NCT04362930
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.

Condition or disease
Neurologic Manifestations Psychiatric Disorders COVID-19

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders: An Observational Study of the Covid-19 Neurological and Psychiatric Manifestations
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : April 24, 2022
Estimated Study Completion Date : April 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Group/Cohort
Neurological and psychiatric impact of COVID-19
Covid-19 impact in neurological or psychiatric manifestations in patients with Covid-19 infection
Impact of Covid-19 in patients with neurological pathology
patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection



Primary Outcome Measures :
  1. Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19 [ Time Frame: 12 months ]
    Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19


Secondary Outcome Measures :
  1. Progression of pre-existing neurological or psychiatric pathologies [ Time Frame: 12 months ]
    Impact on neurological or psychiatric disease trajectories assessed by severity scores or subjective progression (improved, stable, impaired) during and after COVID-19 pathology in patients with pre-existing neurological and psychiatric diseases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Covid-19 infection showing neurological or psychiatric symptoms and patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection
Criteria

Inclusion Criteria:

  • Age of 18 years or over
  • Patient followed for a neurological or psychiatric pathology OR Patient consulting and presenting a neurological or psychiatric impairment AND
  • Presenting a COVID-19 infection defined by at least one of the following three criteria:

    • Biological diagnosis by any method for direct detection of the virus (Covid-19 positive PCR) or recent infection (serology)
    • Typical chest imaging (CT scan or X-ray) in an epidemic area
    • Clinical-biological data leading to a strong suspicion of current or past Covid-19 infection
  • Non-opposition of the participant, relative or guardian to the research

Exclusion Criteria:

  • Patient under safety measure

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): NCT04362930


Contacts
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Contact: CECILE DELORME, MD 142161802 ext +33 cecile.delorme@aphp.fr
Contact: Jean-Christophe CORVOL, MD,PHD 142161799 ext +33 jean-christophe.corvol@aphp.fr

Locations
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France
Hôpital Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: cécile Delorme, MD    1 42 16 18 02 ext +33    cecile.delorme@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Additional Information:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04362930    
Other Study ID Numbers: APHP200525
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
ENCEPHALOPATHY
ENCEPHALITIS
STROKE
CONFUSION
DELIRIUM
DEPRESSION
POST TRAUMATIC STRESS DISORDER
Additional relevant MeSH terms:
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Neurologic Manifestations
Disease
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Nervous System Diseases