COVID-19ZoomCOVIDNCT05197296
Zooming in on Cerebral Abnormalities in Severely Affected COVID-19 Patients
An observational study of COVID-19 and Intensive Care Unit, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Intensive Care Unit
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jun 2022to Oct 2024
- 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: The population consists of adult patients who survived a COVID-19 infection for which ICU hospital admission was necessary during the second/third pandemic wave (October 2020 - ongoing).
Who may be able to join
- Proven COVID-19 infection for which participant was admitted to the ICU for at least 3 days
- Included in the MaastrICCht cohort (a large database of serial measurements collected during ICU stay from patients with COVID-19 admitted to the ICU in the Maastricht University Medical Center+)
- Informed consent is given
- Sufficient command of the Dutch language to follow test instructions and understand the information letter, informed consent, and questionnaires
Who cannot join
- Objective cognitive impairments before hospital admission for the COVID-19 infection
- An unexpected incident leading to severe neurological damage after hospital discharge (such as stroke or traumatic brain injury)
- Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker, claustrophobia, pregnancy, and tattoos in the head/neck region)
- Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
- Contra-indications for a gadolinium-based MRI contrast agent (known allergy or insufficient kidney function determined by an eGFR < 30 mL/min)
- Physical inability to travel to one of the locations (e.g. bedridden patients)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229HX
About this study
Official title: Zooming in on Cerebral Abnormalities in Severely Affected COVID-19 Patients: a 3T and 7T MRI Study
Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination with widespread hypercoagulopathy and thrombosis. Using novel MRI techniques, blood-brain barrier (BBB) permeability, as well as other microstructural and microvascular properties of the brain tissue, will be assessed non-invasively in COVID-19 ICU survivors approximately one year after ICU admission and compared to serial clinical and laboratory measurements of hypercoagulation and inflammation during the (ICU) admission. This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. In addition, neuropsychological tests and an objective smell/taste test will be used to evaluate neuropsychological status and sense of smell/taste. By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.
Read the detailed description
Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination with widespread hypercoagulopathy and thrombosis. Using novel MRI techniques, blood-brain barrier (BBB) permeability, as well as other microstructural and microvascular properties of the brain tissue, will be assessed non-invasively in COVID-19 ICU survivors approximately 12-24 months after ICU admission and compared to serial clinical and laboratory measurements of hypercoagulation and inflammation during the (ICU) admission.
This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.
This is a mono-center follow-up cohort study with measurements at 12-24 months post hospital discharge. This study will include 70 adults who survived a severe COVID-19 infection for whom ICU admission was necessary during the second/third COVID wave (period October 2020- ongoing). These patients will be recruited from the MaastrICCht cohort from the Department of Intensive Care (MUMC+).
Patients will undergo an MRI scan (3T) and optionally a second MRI scan (7T) of approximately 60 minutes each. These scans will lead to insights in microstructural and microvascular abnormalities, BBB impairment, and in possible effects of a severe COVID-19 infection on the brainstem and the glymphatic system. In addition to the MRI measurements, blood samples will be drawn (approximately 20ml) to evaluate ICU follow-up levels of hypercoagulation and inflammation biomarkers. Follow-up short neuropsychological tests and two short questionnaires will be used to assess cognitive, neurological, olfaction and functional status. A brief objective smell and taste testing will be done to get an objective measure of sense of smell and taste.
By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.
- Conditions
- COVID-19, Intensive Care Unit
- Keywords
- Magnetic Resonance Imaging, Intensive Care Unit, COVID-19, SARS-CoV-2
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological outcome
MRI abnormalities, focusing on vascular abnormalities and olfactory tractus (3T MRI), and lymphatics and the brainstem (7T MRI).
Measured: 12-24 months post ICU admission
Neurological outcome
Residual neurological symptoms (including sense of smell/taste) and functional status.
Measured: 12-24 months post ICU admission
Clinical outcome
severity of disease scores, (serial) factors of hyper coagulability and inflammation during ICU admission, neurological and cardiovascular (arterial/venous) complications during hospital admission.
Measured: 12-24 months post ICU admission
Secondary outcomes (1)
Neuropsychological outcome
Global deficits in cognitive and neurological functioning, objective changes in or loss of smell/taste, and residual signs of inflammation and hypercoagulability.
Measured: 12-24 months post ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start20 Jun 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcel JH Ariës, PhD/MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197296
- Sponsor's protocol ID
- 79868
- Acronym
- ZoomCOVID
- Status last verified
- Jun 2022
- First submitted
- 17 Jan 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zooming in on Cerebral Abnormalities in Severely Affected COVID-19 Patients: a 3T and 7T MRI Study
- ClinicalTrials.gov ID
- NCT05197296
- Acronym / sponsor ID
- ZoomCOVID / 79868
- Conditions
- COVID-19, Intensive Care Unit
- Keywords
- Magnetic Resonance Imaging, Intensive Care Unit, COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 19 Jan 2022 (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.
Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination with widespread hypercoagulopathy and thrombosis. Using novel MRI techniques, blood-brain barrier (BBB) permeability, as well as other microstructural and microvascular properties of the brain tissue, will be assessed non-invasively in COVID-19 ICU survivors approximately one year after ICU admission and compared to serial clinical and laboratory measurements of hypercoagulation and inflammation during the (ICU) admission. This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. In addition, neuropsychological tests and an objective smell/taste test will be used to evaluate neuropsychological status and sense of smell/taste. By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.
Detailed description
Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination with widespread hypercoagulopathy and thrombosis. Using novel MRI techniques, blood-brain barrier (BBB) permeability, as well as other microstructural and microvascular properties of the brain tissue, will be assessed non-invasively in COVID-19 ICU survivors approximately 12-24 months after ICU admission and compared to serial clinical and laboratory measurements of hypercoagulation and inflammation during the (ICU) admission.
This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.
This is a mono-center follow-up cohort study with measurements at 12-24 months post hospital discharge. This study will include 70 adults who survived a severe COVID-19 infection for whom ICU admission was necessary during the second/third COVID wave (period October 2020- ongoing). These patients will be recruited from the MaastrICCht cohort from the Department of Intensive Care (MUMC+).
Patients will undergo an MRI scan (3T) and optionally a second MRI scan (7T) of approximately 60 minutes each. These scans will lead to insights in microstructural and microvascular abnormalities, BBB impairment, and in possible effects of a severe COVID-19 infection on the brainstem and the glymphatic system. In addition to the MRI measurements, blood samples will be drawn (approximately 20ml) to evaluate ICU follow-up levels of hypercoagulation and inflammation biomarkers. Follow-up short neuropsychological tests and two short questionnaires will be used to assess cognitive, neurological, olfaction and functional status. A brief objective smell and taste testing will be done to get an objective measure of sense of smell and taste.
By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of adult patients who survived a COVID-19 infection for which ICU hospital admission was necessary during the second/third pandemic wave (October 2020 - ongoing).
Key inclusion criteria (4 listed)
- Proven COVID-19 infection for which participant was admitted to the ICU for at least 3 days
- Included in the MaastrICCht cohort (a large database of serial measurements collected during ICU stay from patients with COVID-19 admitted to the ICU in the Maastricht University Medical Center+)
- Informed consent is given
- Sufficient command of the Dutch language to follow test instructions and understand the information letter, informed consent, and questionnaires
Key exclusion criteria (6 listed)
- Objective cognitive impairments before hospital admission for the COVID-19 infection
- An unexpected incident leading to severe neurological damage after hospital discharge (such as stroke or traumatic brain injury)
- Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker, claustrophobia, pregnancy, and tattoos in the head/neck region)
- Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
- Contra-indications for a gadolinium-based MRI contrast agent (known allergy or insufficient kidney function determined by an eGFR < 30 mL/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiological outcome
Time frame: 12-24 months post ICU admission
MRI abnormalities, focusing on vascular abnormalities and olfactory tractus (3T MRI), and lymphatics and the brainstem (7T MRI).
Neurological outcome
Time frame: 12-24 months post ICU admission
Residual neurological symptoms (including sense of smell/taste) and functional status.
Clinical outcome
Time frame: 12-24 months post ICU admission
severity of disease scores, (serial) factors of hyper coagulability and inflammation during ICU admission, neurological and cardiovascular (arterial/venous) complications during hospital admission.
1 secondary outcome
Neuropsychological outcome
Time frame: 12-24 months post ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marcel JH Ariës, PhD/MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Intensive Care Unit, run by Maastricht University Medical Center at 1 site in Netherlands.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
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?
Radiological outcome (time frame: 12-24 months post ICU admission). The study lists 3 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 29 Jun 2022.