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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Jun 2021

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

March 2, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed

Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

March 2, 2021

Last Update Submit

August 22, 2023

Conditions

Covid19 Delirium Post-traumatic Stress Disorder

Keywords

COVID-19deliriummicroglial activationSARS-CoV-2 neurotropism

Outcome Measures

Primary Outcomes (2)

PET imaging examination
Intensity and topography of \[18F\]DPA-714-labeled microglial activation in vivo in PET imaging examination
Day 0
PET imaging examination
Intensity and topography of \[18F\]DPA-714-labeled microglial activation in vivo in PET imaging examination
Month 3

Secondary Outcomes (6)

SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen
Day 0
SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen
Month 3
SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen
Day 0
SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen
Month 3
multimodal MRI in acute delirium phase
Day 0
+1 more secondary outcomes

Study Arms (1)

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.

Biological: serology testing profiles descriptionBiological: immune response characterizationOther: in vivo brain PET-TSPO acquisitionsOther: brain MRI assessmentBehavioral: neurocognitive assessment

Interventions

serology testing profiles descriptionBIOLOGICAL

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

Also known as: biomarkers