Clinical trial NCT04937582: Cognitive and Psychological Disorders After Severe COVID-19 Infection
Official title: Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID 19
Keywords: COVID 19 cognitive impairement
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
name: University Hospital, Strasbourg, France
name: Centre Hospitalier Régional Metz-Thionville
name: Centre hospitalier Epinal
name: Hopitaux Civils de Colmar
First posted: 2021-06-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Characterization of cognitive and psychological disorders 1 year after COVID-19 infection
timeFrame: up to 1 year
Secondary outcomes:
measure: Frequency of cognitive and psychological disorders 1 year and 2 years after COVID-19 infection
timeFrame: up to 2 years
measure: Severity of cognitive and psychological disorders 1 year after COVID-19 infection
timeFrame: up to 1 year
measure: Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
timeFrame: up to 2 years
measure: Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Nancy University Hospital, Department of Neurology
Study officials:
References: