Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.

NCT ID: NCT04785157

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-06-30

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.

Conditions

Covid19; Delirium; Post-traumatic Stress Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

severe COVID-19 patients with delirium

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.

serology testing profiles description

Intervention Type: BIOLOGICAL

SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)

immune response characterization

Intervention Type: BIOLOGICAL

systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)

in vivo brain PET-TSPO acquisitions

Intervention Type: OTHER

in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia)

brain MRI assessment

Intervention Type: OTHER

structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)

neurocognitive assessment

Intervention Type: BEHAVIORAL

multi-domains neurocognitive assessment

Interventions

serology testing profiles description

SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)

Intervention Type: BIOLOGICAL

immune response characterization

systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)

Intervention Type: BIOLOGICAL

in 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)

Intervention Type: OTHER

brain MRI assessment

structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)

Intervention Type: OTHER

neurocognitive assessment

multi-domains neurocognitive assessment

Intervention Type: BEHAVIORAL

Other Intervention Names

biomarkers

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stein SILVA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital of Toulouse

Toulouse, , France

CHRU Tours

Tours, , France

Countries

France

Other Identifiers

2020-005827-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RC31/20/0441

Identifier Type: -

Identifier Source: org_study_id