Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium. (BRAINSTORM)

Toulouse University Hospital

Status: Completed

Conditions: Post-traumatic Stress Disorder; Delirium; Covid19

Treatments: Other: brain MRI assessment; Behavioral: neurocognitive assessment; Biological: immune response characterization; Biological: serology testing profiles description; Other: in vivo brain PET-TSPO acquisitions

Study type: Observational

Funder types: Other

Identifiers

NCT04785157

RC31/20/0441

2020-005827-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 1 patient group

severe COVID-19 patients with delirium

Description:

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.

Treatment:

Other: brain MRI assessment

Other: in vivo brain PET-TSPO acquisitions

Behavioral: neurocognitive assessment

Biological: immune response characterization

Biological: serology testing profiles description