Cognitive and Psychological Disorders After Severe COVID-19 Infection

NCT04937582 | Completed

• 1 other identifier: 2021-A00447-34
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

As COVID-19 pandemic is still ongoing, patients follow-up begins to reveal cognitive and psychological disorders. There are not yet well described, neither their physiopathology. This study will consist in the detection and characterization of cognitive and psychological impairments in young patients under 65 years of age who have been hospitalized more than 72 hours for a severe COVID-19 infection.

Conditions

COVID 19

Keywords

COVID 19 cognitive impairement

Outcome Measures

Primary Outcomes (1)

• Characterization of cognitive and psychological disorders 1 year after COVID-19 infection

  Perfomance to cognitive assessment

  up to 1 year

Secondary Outcomes (4)

• Frequency of cognitive and psychological disorders 1 year and 2 years after COVID-19 infection

  up to 2 years

• Severity of cognitive and psychological disorders 1 year after COVID-19 infection

  up to 1 year

• Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care

  up to 2 years

• Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care

  up to 2 years

Study Arms (2)

Confirmed cognitive disorder

EXPERIMENTAL

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)

Diagnostic Test: Cognitive assessment; Diagnostic Test: Imaging; Diagnostic Test: Routine care; Other: Psychiatric evaluation

Absence of cognitive disorder

EXPERIMENTAL

Patients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1.

Diagnostic Test: Cognitive assessment; Other: Psychiatric evaluation

Interventions

Cognitive assessment DIAGNOSTIC_TEST

Complete cognitive and psychological assessment

Absence of cognitive disorder; Confirmed cognitive disorder

Imaging DIAGNOSTIC_TEST

Brain MRI Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose)

Confirmed cognitive disorder

Routine care DIAGNOSTIC_TEST

Electroencephalogram (EEG) Optional: polysomnography, lumbar puncture

Confirmed cognitive disorder

Psychiatric evaluation OTHER

Psychiatric consultation if necessary

Confirmed cognitive disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 65 years of age (at discharge of hospitalization),
• 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.

You may not qualify if:

• Inability to travel to perform the BNP or additional tests,
• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Centre Hospitalier Universitaire de Besancon: collaborator
• University Hospital, Strasbourg, France: collaborator
• Centre Hospitalier Régional Metz-Thionville: collaborator
• Centre hospitalier Epinal: collaborator
• Hopitaux Civils de Colmar: collaborator

Study Sites (1)

Nancy University Hospital, Department of Neurology

Nancy, 54000, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 24, 2021
• Study Start: August 23, 2021
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)