Trials / Completed
CompletedNCT04937582
Cognitive and Psychological Disorders After Severe COVID-19 Infection
Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2021-08-23
- Primary completion
- 2023-09-27
- Completion
- 2023-09-27
- First posted
- 2021-06-24
- Last updated
- 2024-02-09
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04937582. Inclusion in this directory is not an endorsement.