COVID 19NEUROCOG-COVIDNCT04937582
Cognitive and Psychological Disorders After Severe COVID-19 Infection
A study testing Cognitive assessment, Imaging and Routine care in people with COVID 19, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID 19
- What is being tested?
- Cognitive assessment, Imaging and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2021to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients
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.
Read the 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
- COVID 19
- Being tested
- Cognitive assessment, Imaging, Routine care, Psychiatric evaluation
- Keywords
- COVID 19 cognitive impairement
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentDiagnostic test
Complete cognitive and psychological assessment
ImagingDiagnostic test
Brain MRI
Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose)
Routine careDiagnostic test
Electroencephalogram (EEG)
Optional: polysomnography, lumbar puncture
Psychiatric evaluationOther
Psychiatric consultation if necessary
Psychiatric evaluationOther
Psychiatric consultation if necessary (before the end of their participation in the study)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Cognitive assessment; Diagnostic Test: Imaging; Diagnostic Test: Routine care; Other: Psychiatric evaluation |
| Absence of cognitive disorder | Experimental | Patients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1. Receives: Diagnostic Test: Cognitive assessment; Other: Psychiatric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of cognitive and psychological disorders 1 year after COVID-19 infection
Perfomance to cognitive assessment
Measured: up to 1 year
Secondary outcomes (4)
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
Measured: up to 2 years
Severity of cognitive and psychological disorders 1 year after COVID-19 infection
Perfomance to cognitive assessment
Measured: up to 1 year
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Cognitive assessment
Measured: 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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start23 Aug 2021
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon, University Hospital, Strasbourg, France, Centre Hospitalier Régional Metz-Thionville, Centre hospitalier Epinal, Hopitaux Civils de Colmar
- Responsible party
- Principal investigator, Lucie HOPES, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937582
- Sponsor's protocol ID
- 2021-A00447-34
- Acronym
- NEUROCOG-COVID
- Status last verified
- Feb 2024
- First submitted
- 28 May 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients
- ClinicalTrials.gov ID
- NCT04937582
- Acronym / sponsor ID
- NEUROCOG-COVID / 2021-A00447-34
- Conditions
- COVID 19
- Keywords
- COVID 19 cognitive impairement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon, University Hospital, Strasbourg, France, Centre Hospitalier Régional Metz-Thionville, Centre hospitalier Epinal, Hopitaux Civils de Colmar
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed cognitive disorder | Experimental | Diagnostic Test: Cognitive assessment, Diagnostic Test: Imaging, Diagnostic Test: Routine care, Other: Psychiatric evaluationPatients 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 | Diagnostic Test: Cognitive assessment, Other: Psychiatric evaluationPatients with abnormal QPC score at screening and absence of cognitive disorder on the neuropsychological assessment during Visit V1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assessmentComplete cognitive and psychological assessment | Diagnostic test | Absence of cognitive disorder, Confirmed cognitive disorder |
| ImagingBrain MRI Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose) | Diagnostic test | Confirmed cognitive disorder |
| Routine careElectroencephalogram (EEG) Optional: polysomnography, lumbar puncture | Diagnostic test | Confirmed cognitive disorder |
| Psychiatric evaluationPsychiatric consultation if necessary | Other | Confirmed cognitive disorder |
| Psychiatric evaluationPsychiatric consultation if necessary (before the end of their participation in the study) | Other | Absence of cognitive disorder |
Primary outcome
Characterization of cognitive and psychological disorders 1 year after COVID-19 infection
Time frame: up to 1 year
Perfomance to cognitive assessment
4 secondary outcomes
Frequency of cognitive and psychological disorders 1 year and 2 years after COVID-19 infection
Time frame: up to 2 years
Severity of cognitive and psychological disorders 1 year after COVID-19 infection
Time frame: up to 1 year
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Time frame: up to 2 years
Evaluate the prognosis of cognitive and psychological disorders at 2 years according to the proposed medical care
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive assessment, Imaging and Routine care in people with COVID 19, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of cognitive and psychological disorders 1 year after COVID-19 infection (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.