Clinical trial NCT04785157: Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.
Official title: SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Delirium
Post-traumatic Stress Disorder
Keywords: COVID-19
delirium
microglial activation
SARS-CoV-2 neurotropism
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-03-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients from hospital

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.

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

Primary outcomes:
measure: PET imaging examination
timeFrame: Day 0
measure: PET imaging examination
timeFrame: Month 3
Secondary outcomes:
measure: SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen
timeFrame: Day 0
measure: SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen
timeFrame: Month 3
measure: SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen
timeFrame: Day 0
measure: SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen
timeFrame: Month 3
measure: multimodal MRI in acute delirium phase
timeFrame: Day 0
measure: multimodal MRI 3 months after the acute delirium phase
timeFrame: month 3
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: University Hospital, Toulouse
name: Stein SILVA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: