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Completed

NCT Number: NCT04937582

Cognitive and Psychological Disorders After Severe COVID-19 Infection

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nancy University Hospital, Department of Neurology

Nancy, 54000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive assessment

Diagnostic Test

Complete cognitive and psychological assessment

Imaging

Diagnostic Test

Brain MRI

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

routine care

Diagnostic Test

Electroencephalogram (EEG)

Optional: polysomnography, lumbar puncture

Psychiatric evaluation

Other

Psychiatric consultation if necessary

Primary outcomes

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

    Time frame: up to 1 year

    Perfomance to cognitive assessment

Secondary outcomes

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

    Time frame: up to 2 years

    Number of patients with confirmed cognitive and/or psychological disorder compared to the total number of patients who completed the QPC scale

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

    Time frame: up to 1 year

    Perfomance to cognitive assessment

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

    Time frame: up to 2 years

    Cognitive assessment

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

    Time frame: up to 2 years

    Change from baseline in professional status

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NEUROCOG-COVID

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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