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Cognitive and Psychological Disorders After Severe COVID-19 Infection (NEUROCOG-COVID)

Primary Purpose

COVID 19

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive assessment
Imaging
Routine care
Psychiatric evaluation
Psychiatric evaluation
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID 19 focused on measuring COVID 19 cognitive impairement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nancy University Hospital, Department of NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Confirmed cognitive disorder

Absence of cognitive disorder

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Characterization of cognitive and psychological disorders 1 year after COVID-19 infection
Perfomance to cognitive assessment

Secondary Outcome Measures

Frequency of cognitive and psychological disorders 1 year and 2 years after COVID-19 infection
Number of patients with confirmed cognitive and/or psychological disorder compared to the total number of patients who completed the QPC scale
Severity of cognitive and psychological disorders 1 year after COVID-19 infection
Perfomance to cognitive assessment
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Cognitive assessment
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Change from baseline in professional status

Full Information

First Posted
May 28, 2021
Last Updated
July 20, 2022
Sponsor
Central Hospital, Nancy, France
Collaborators
Centre Hospitalier Universitaire de Besancon, University Hospital, Strasbourg, France, Centre Hospitalier Régional Metz-Thionville, Centre hospitalier Epinal, Hopitaux Civils de Colmar
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1. Study Identification

Unique Protocol Identification Number
NCT04937582
Brief Title
Cognitive and Psychological Disorders After Severe COVID-19 Infection
Acronym
NEUROCOG-COVID
Official Title
Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Centre Hospitalier Universitaire de Besancon, University Hospital, Strasbourg, France, Centre Hospitalier Régional Metz-Thionville, Centre hospitalier Epinal, Hopitaux Civils de Colmar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Initial consecutive screening of patients (<65 years) hospitalized between the 01/10/2020 and the 01/07/2021 for more than 72 hours for COVID-19 infection in 6 hospitals of the East of France. If detection of cognitive complaints (QPC scale : Questionnaire of cognitive complaints), continuation of the study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
Keywords
COVID 19 cognitive impairement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Confirmed cognitive disorder
Arm Type
Experimental
Arm Description
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)
Arm Title
Absence of cognitive disorder
Arm Type
Experimental
Arm Description
Patients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cognitive assessment
Intervention Description
Complete cognitive and psychological assessment
Intervention Type
Diagnostic Test
Intervention Name(s)
Imaging
Intervention Description
Brain MRI Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose)
Intervention Type
Diagnostic Test
Intervention Name(s)
Routine care
Intervention Description
Electroencephalogram (EEG) Optional: polysomnography, lumbar puncture
Intervention Type
Other
Intervention Name(s)
Psychiatric evaluation
Intervention Description
Psychiatric consultation if necessary
Intervention Type
Other
Intervention Name(s)
Psychiatric evaluation
Intervention Description
Psychiatric consultation if necessary (before the end of their participation in the study)
Primary Outcome Measure Information:
Title
Characterization of cognitive and psychological disorders 1 year after COVID-19 infection
Description
Perfomance to cognitive assessment
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Frequency of cognitive and psychological disorders 1 year and 2 years after COVID-19 infection
Description
Number of patients with confirmed cognitive and/or psychological disorder compared to the total number of patients who completed the QPC scale
Time Frame
up to 2 years
Title
Severity of cognitive and psychological disorders 1 year after COVID-19 infection
Description
Perfomance to cognitive assessment
Time Frame
up to 1 year
Title
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Description
Cognitive assessment
Time Frame
up to 2 years
Title
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Description
Change from baseline in professional status
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie HOPES, MD
Phone
+33383852377
Email
l.hopes@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
CLAIRE BANASIAK
Email
c.banasiak@chru-nancy.fr
Facility Information:
Facility Name
Nancy University Hospital, Department of Neurology
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie HOPES, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive and Psychological Disorders After Severe COVID-19 Infection

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