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

Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients

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.

Study Overview

• Status: Completed
• Conditions: COVID 19
• Intervention / Treatment: Diagnostic test: Cognitive assessment; Diagnostic test: Imaging; Diagnostic test: Routine care; Other: Psychiatric evaluation; Other: Psychiatric evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Nancy University Hospital, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Diagnostic test: Cognitive assessment; Complete cognitive and psychological assessment; Diagnostic test: Imaging; Brain MRI Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose); Diagnostic test: Routine care; Electroencephalogram (EEG) Optional: polysomnography, lumbar puncture; Other: Psychiatric evaluation; Psychiatric consultation if necessary; Other: Psychiatric evaluation; Psychiatric consultation if necessary (before the end of their participation in the study)
Experimental: Absence of cognitive disorder; Patients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1.	Diagnostic test: Cognitive assessment; Complete cognitive and psychological assessment; Other: Psychiatric evaluation; Psychiatric consultation if necessary; Other: Psychiatric evaluation; Psychiatric consultation if necessary (before the end of their participation in the study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of cognitive and psychological disorders 1 year after COVID-19 infection	Perfomance to cognitive assessment	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 2 years
Severity of cognitive and psychological disorders 1 year after COVID-19 infection	Perfomance to cognitive assessment	up to 1 year
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care	Cognitive assessment	up to 2 years
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care	Change from baseline in professional status	up to 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID 19 cognitive impairement
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Mental Disorders
• Other Study ID Numbers: 2021-A00447-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No