Covid19, Delirium, Post-traumatic Stress Disorder
Conditions
Keywords
COVID-19, delirium, microglial activation, SARS-CoV-2 neurotropism
Brief summary
Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.
Detailed description
The BRAINSTORM project aims at creating a proof-of-concept dataset from severe COVID-19 patients with delirium. For the first time, this longitudinal study will rely on repeated and concomitant: i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF), ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF), iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia), iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity), v) multi-domains neurocognitive assessment. This dataset will be made FAIR to allow open data use and to prepare future studies.
Interventions
BIOLOGICALserology testing profiles description
SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)
BIOLOGICALimmune response characterization
systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)
OTHERin vivo brain PET-TSPO acquisitions
in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia)
OTHERbrain MRI assessment
structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)
BEHAVIORALneurocognitive assessment
multi-domains neurocognitive assessment
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Toulouse
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (male or female \> or = 18 years) * COVID-19 (positive respiratory track PCR test \< 30 days) * Delirium (CAM-ICU criteria) * informed and written consent to participate in the study by patient's surrogate.
Exclusion criteria
* medical decision of withdrawal of life sustaining treatments previous to patients recruitment * former neurological or psychiatric disability * MRI or PET scan contraindication * pregnancy * hemodynamic or respiratory failure precluding patient's transport / MRI or PET scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET imaging examination | Day 0 | Intensity and topography of \[18F\]DPA-714-labeled microglial activation in vivo in PET imaging examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen | Month 3 | SARS-CoV-2 quasispecies detection in blood specimen |
| SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen | Day 0 | SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen |
| SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen | Day 0 | SARS-CoV-2 quasispecies detection in blood specimen |
| multimodal MRI in acute delirium phase | Day 0 | Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI) |
| multimodal MRI 3 months after the acute delirium phase | month 3 | Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI) |
| SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen | Month 3 | SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen |
Countries
France
Outcome results
None listed