Cognitive and Psychological Disorders After Severe COVID-19 Infection
NCT ID: NCT04937582
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2021-08-23
2023-09-27
Brief Summary
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Detailed Description
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Evaluation with cognitive assessments, morphological and functional imaging and EEG will be done at 9 ± 3 months and 2 years after initial hospitalisation. Data will be collected concerning social and professional outcome.
An ancillary study will be conducted at the Nancy University Hospital. This ancillary study is entitled "TRAUMA-COV: Screening and therapeutic proposal of post-traumatic sequelae in the aftermath of a severe Covid-19 in young subjects". The main objective of this study is to evaluate the incidence of post-Covid-19 post-traumatic disorders (post-traumatic stress disorder, psychogenic and somatoform dissociative tendency, neurological dissociative disorder) in a longitudinal way. This optional study will be offered to all patients from the main study who meet the selection criteria.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Confirmed cognitive disorder
Patients with abnormal QPC score at screening visit and confirmed cognitive disorder on the neuropsychological assessment during Visit V1.
Intervention Completed by MRI (magnetic resonance imaging), EEG (Electroencephalogram) and possible psychiatric evaluation at Visit 1B.
Follow-up 2 years after initial hospitalisation (Visit 2 : neuropsychological assessment ; if needed MRI, EEG, lumbar puncture)
Cognitive assessment
Complete cognitive and psychological assessment
Imaging
Brain MRI
Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose)
Routine care
Electroencephalogram (EEG)
Optional: polysomnography, lumbar puncture
Psychiatric evaluation
Psychiatric consultation if necessary
Absence of cognitive disorder
Patients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1.
Cognitive assessment
Complete cognitive and psychological assessment
Psychiatric evaluation
Psychiatric consultation if necessary (before the end of their participation in the study)
Interventions
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Cognitive assessment
Complete cognitive and psychological assessment
Imaging
Brain MRI
Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose)
Routine care
Electroencephalogram (EEG)
Optional: polysomnography, lumbar puncture
Psychiatric evaluation
Psychiatric consultation if necessary
Psychiatric evaluation
Psychiatric consultation if necessary (before the end of their participation in the study)
Eligibility Criteria
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Inclusion Criteria
* Patient hospitalized for more than 72 hours (in intensive care or conventional sector) for a COVID-19 infection defined by a positive PCR (Polymerase Chain Reaction) test and/or typical aspect on thoracic scanner,
* Patient discharged from hospital between 01/10/2020 and 01/04/2021,
* Patient with suspected cognitive impairment (obtaining a pathologic QPC score) during the phone screening,
* Patient having received complete information on the organization of the research and having given written informed consent (or a third person, independent of the investigator and the sponsor, in case of inability to read or write),
* Patient affiliated with a social security plan or beneficiary of such a plan,
* Patient with a sufficient level of written French comprehension to complete the cognitive assessment.
Exclusion Criteria
* Contraindication to perform brain MRI (pacemaker, etc.),
* Presence of chronic neurological diseases (multiple sclerosis, neurodegenerative disease, epilepsy) and/or major cognitive disorders (stroke, head trauma) pre-COVID-19,
* Presence of psychiatric disorder historys (bipolar or psychotic illness) pre-COVID-19,
* Patients with very extensive post-COVID-19 brain damage leading to impossibility to realise cognitive assessment,
* Addictive history or comorbidities (alcoholism, drug use) with sequelae of cognitive impairment,
* Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
18 Years
65 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
University Hospital, Strasbourg, France
OTHER
Centre Hospitalier Régional Metz-Thionville
OTHER
Centre hospitalier Epinal
UNKNOWN
Hopitaux Civils de Colmar
OTHER
Central Hospital, Nancy, France
OTHER
Responsible Party
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Lucie HOPES
Principal Investigator
Locations
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Nancy University Hospital, Department of Neurology
Nancy, , France
Countries
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Other Identifiers
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2021-A00447-34
Identifier Type: -
Identifier Source: org_study_id
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