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Clinical Trials/NCT04937582
NCT04937582
Completed
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country76 target enrollmentAugust 23, 2021
ConditionsCOVID 19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID 19
Sponsor
Central Hospital, Nancy, France
Enrollment
76
Locations
1
Primary Endpoint
Characterization of cognitive and psychological disorders 1 year after COVID-19 infection
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2021
End Date
September 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Lucie HOPES

Principal Investigator

Central Hospital, Nancy, France

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.

Outcomes

Primary Outcomes

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

Time Frame: up to 1 year

Perfomance to cognitive assessment

Secondary Outcomes

  • 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)

Study Sites (1)

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