Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Besancon | OTHER |
| University Hospital, Strasbourg, France | OTHER |
| Centre Hospitalier Régional Metz-Thionville | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Confirmed cognitive disorder | Experimental | 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) |
|
| Absence of cognitive disorder | Experimental | Patients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive assessment | Diagnostic Test | Complete cognitive and psychological assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of cognitive and psychological disorders 1 year after COVID-19 infection | Perfomance to cognitive assessment | up to 1 year |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nancy University Hospital, Department of Neurology | Nancy | 54000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
| Centre hospitalier Epinal |
| UNKNOWN |
| Hopitaux Civils de Colmar | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Psychiatric evaluation | Other | Psychiatric consultation if necessary (before the end of their participation in the study) |
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |