Covid19BRAINSTORMNCT04785157
Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.
An observational study of Covid19 and Delirium, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Delirium, Post-traumatic Stress Disorder
- What is being tested?
- serology testing profiles description, immune response characterization and in vivo brain PET-TSPO acquisitions
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from hospital
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
About this study
Official title: SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium
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.
Read the 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
- Being tested
- serology testing profiles description, immune response characterization, in vivo brain PET-TSPO acquisitions, brain MRI assessment, neurocognitive assessment
- Keywords
- COVID-19, delirium, microglial activation, SARS-CoV-2 neurotropism
- Medical subject headings
- COVID-19, Delirium, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serology testing profiles descriptionBiological
Also called biomarkers
SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)
immune response characterizationBiological
systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)
in vivo brain PET-TSPO acquisitionsOther
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 assessmentOther
structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)
neurocognitive assessmentBehavioural
multi-domains neurocognitive assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: serology testing profiles description; Biological: immune response characterization; Other: in vivo brain PET-TSPO acquisitions; Other: brain MRI assessment; Behavioral: neurocognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET imaging examination
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
Measured: Day 0
PET imaging examination
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
Measured: Month 3
Secondary outcomes (6)
SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen
SARS-CoV-2 quasispecies detection in blood specimen
Measured: Day 0
SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen
SARS-CoV-2 quasispecies detection in blood specimen
Measured: Month 3
SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen
SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen
Measured: Day 0
SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen
SARS-CoV-2 quasispecies detection in cerebrospinal fluid specimen
Measured: Month 3
multimodal MRI in acute delirium phase
Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)
Measured: Day 0
multimodal MRI 3 months after the acute delirium phase
Imaging criteria: Structural-functional disconnects at the whole brain level (multimodal MRI)
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stein SILVA, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785157
- Sponsor's protocol ID
- RC31/20/0441
- Other IDs
- 2020-005827-35
- Acronym
- BRAINSTORM
- Status last verified
- Aug 2023
- First submitted
- 2 Mar 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium
- ClinicalTrials.gov ID
- NCT04785157
- Acronym / sponsor ID
- BRAINSTORM / RC31/20/0441
- Conditions
- Covid19, Delirium, Post-traumatic Stress Disorder
- Keywords
- COVID-19, delirium, microglial activation, SARS-CoV-2 neurotropism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe COVID-19 patients with delirium | – | Biological: serology testing profiles description, Biological: immune response characterization, Other: in vivo brain PET-TSPO acquisitions, Other: brain MRI assessment, Behavioral: neurocognitive assessmenti) 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serology testing profiles descriptionAlso: biomarkersSARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF) | Biological | severe COVID-19 patients with delirium |
| immune response characterizationsystemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF) | Biological | severe COVID-19 patients with delirium |
| in vivo brain PET-TSPO acquisitionsin vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia) | Other | severe COVID-19 patients with delirium |
| brain MRI assessmentstructural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity) | Other | severe COVID-19 patients with delirium |
| neurocognitive assessmentmulti-domains neurocognitive assessment | Behavioural | severe COVID-19 patients with delirium |
Primary outcome
PET imaging examination
Time frame: Day 0
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
PET imaging examination
Time frame: Month 3
Intensity and topography of [18F]DPA-714-labeled microglial activation in vivo in PET imaging examination
6 secondary outcomes
SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen
Time frame: Day 0
SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen
Time frame: Month 3
SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen
Time frame: Day 0
SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen
Time frame: Month 3
multimodal MRI in acute delirium phase
Time frame: Day 0
multimodal MRI 3 months after the acute delirium phase
Time frame: month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein SILVA, MD, PhD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Delirium, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET imaging examination (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.