Long Covid19NCT05492292
Long-term Effects of SARS-CoV-2 on the Central Nervous System and One-year Follow-up of "Long COVID-19" Patients
A study testing Perfusion brain scintigraphy imaging in people with Long Covid19, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the seventh coronavirus known to infect humans, and causing coronavirus disease 2019 (COVID-19). . Since its emergence in December 2019, in Wuhan, China, SARS-CoV-2 has led to a global pandemic with almost 188 million cases and 4 million COVID-19 related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid19
- What is being tested?
- Perfusion brain scintigraphy imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years;
- Physically and mentally able to fill out questionnaires;
- Suspicion and/or confirmation of COVID-19 infection, managed on an out- or inpatient (COVID-19 ward or ICU) basis;
- Residual symptoms at 8 weeks or more after initial SARS-CoV-2 infection.
Who cannot join
- Diagnosed with a neurological syndrome e.g. Parkinson disease, Alzheimer disease, … before SARS-CoV-2 infection;
- Known Dementia or mild cognitive impairment before SARS-CoV-2.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Marie Dominique GAZAGNES, MD
About this study
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the seventh coronavirus known to infect humans, and causing coronavirus disease 2019 (COVID-19). . Since its emergence in December 2019, in Wuhan, China, SARS-CoV-2 has led to a global pandemic with almost 188 million cases and 4 million COVID-19 related deaths reported. Although initially considered as a predominantly acute respiratory illness, it soon became apparent that COVID-19 could also produce neurological manifestations and severe neurological complications. During the acute phase of SARS-CoV-2 infection, about 36% of cases develop neurological symptoms of which 25% can be attributed to the direct involvement of the central nervous system.
There are increasing reports of central and peripheral nervous system involvement. Acute neurological manifestations reported, include, but are not limited to: anosmia, dysgeusia, stroke, encephalomyelitis, meningo-encephalitis, posterior reversible encephalopathy, acute necrotizing encephalopathy, new onset seizures and Guillain-Barre syndrome.
Read more
However, one of the most perplexing aspects of SARS-CoV-2 is that two to four months after their initial (mostly apparently mild) infection, some COVID-19 patients still present a constellation of more chronic neurological symptoms colloquially known as "long COVID-19" syndrome. In these patients, COVID-19 appears to affect long-term brain function and patients have functional complaints as dyspnea, hyposmia/anosmia, dysgeusia/ageusia, but also, and more importantly, memory and cognitive impairment, pain, deadening fatigue, and alterations in sleeping-pattern/insomnia, all of them correlated with typical 18F-FDG brain PET scan abnormalities.
At the beginning of the pandemic, the medical world was not expecting the phenomenon of COVID-19 patients developing persistent neurologically symptoms. However, more than one year after the pandemic, multiple waves of the "long COVID-19" syndrome may be expected to occur worldwide. To face the long tail impact of the COVID-19 pandemic on public health and its social and economic consequences on our society, future research urgently needs to be dedicated to these "long COVID-19" patients in an attempt to determine, understand and manage their symptoms.
A lot of "long COVID-19" patients are desperately searching for help. This project found his origin in the fact that suddenly many patients spontaneously presented with a similar constellation of persistent (chronic) symptoms, months after they had (mostly mild) COVID-19, with many of them being relatively young, without underlying health problems, but unable to work due to cognitive impairment. During the entire study, the opinion and feelings of these patients will be taken in account, all the more so because the majority of these patients were initially left behind.
The primary objective of this study is to determine the different types of neurological dysfunction and clinical manifestations of the "long COVID-19" syndrome and to correlate them to abnormalities/signs on cerebral perfusion scintigraphy. Furthermore, the investigators aim to determine and validate a specific imaging biomarker of post-COVID-19 encephalopathy.
The secondary objective of this study is to determine the best therapeutic modality to treat and improve prognosis of patients with "long COVID-19" syndrome with defined central nervous system impairment.
- Conditions
- Long Covid19
- Being tested
- Perfusion brain scintigraphy imaging
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion brain scintigraphy imagingDiagnostic test
The cerebral perfusion scintigraphy via a SPECT examination aims to analyze the cerebral blood flow and detect possible lesions or inflammations.
| Study group | Role | What they receive |
|---|---|---|
| Long Covid19 patient group | Experimental | Patients with Long Covid19 undergoing perfusion brain scintigraphy Receives: Diagnostic Test: Perfusion brain scintigraphy imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference (1 year versus baseline) in the distribution of hypo-perfused areas in the brain as assessed by cerebral perfusion scintigraphy.
SPECT data were acquired using a standardized protocol. For focal abnormalities of increased or decreased uptake, the anatomical location was described.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start10 Aug 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Dachy, Brugmann University Hospital
- Investigators
- Marie Dominique Gazagnes, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492292
- Sponsor's protocol ID
- CHUB-Neuro-Covid Long
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 8 Aug 2022
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of SARS-CoV-2 on the Central Nervous System and One-year Follow-up of "Long COVID-19" Patients
- ClinicalTrials.gov ID
- NCT05492292
- Acronym / sponsor ID
- CHUB-Neuro-Covid Long
- Conditions
- Long Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Aug 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the seventh coronavirus known to infect humans, and causing coronavirus disease 2019 (COVID-19). . Since its emergence in December 2019, in Wuhan, China, SARS-CoV-2 has led to a global pandemic with almost 188 million cases and 4 million COVID-19 related deaths reported. Although initially considered as a predominantly acute respiratory illness, it soon became apparent that COVID-19 could also produce neurological manifestations and severe neurological complications. During the acute phase of SARS-CoV-2 infection, about 36% of cases develop neurological symptoms of which 25% can be attributed to the direct involvement of the central nervous system.
There are increasing reports of central and peripheral nervous system involvement. Acute neurological manifestations reported, include, but are not limited to: anosmia, dysgeusia, stroke, encephalomyelitis, meningo-encephalitis, posterior reversible encephalopathy, acute necrotizing encephalopathy, new onset seizures and Guillain-Barre syndrome.
However, one of the most perplexing aspects of SARS-CoV-2 is that two to four months after their initial (mostly apparently mild) infection, some COVID-19 patients still present a constellation of more chronic neurological symptoms colloquially known as "long COVID-19" syndrome. In these patients, COVID-19 appears to affect long-term brain function and patients have functional complaints as dyspnea, hyposmia/anosmia, dysgeusia/ageusia, but also, and more importantly, memory and cognitive impairment, pain, deadening fatigue, and alterations in sleeping-pattern/insomnia, all of them correlated with typical 18F-FDG brain PET scan abnormalities.
At the beginning of the pandemic, the medical world was not expecting the phenomenon of COVID-19 patients developing persistent neurologically symptoms. However, more than one year after the pandemic, multiple waves of the "long COVID-19" syndrome may be expected to occur worldwide. To face the long tail impact of the COVID-19 pandemic on public health and its social and economic consequences on our society, future research urgently needs to be dedicated to these "long COVID-19" patients in an attempt to determine, understand and manage their symptoms.
A lot of "long COVID-19" patients are desperately searching for help. This project found his origin in the fact that suddenly many patients spontaneously presented with a similar constellation of persistent (chronic) symptoms, months after they had (mostly mild) COVID-19, with many of them being relatively young, without underlying health problems, but unable to work due to cognitive impairment. During the entire study, the opinion and feelings of these patients will be taken in account, all the more so because the majority of these patients were initially left behind.
The primary objective of this study is to determine the different types of neurological dysfunction and clinical manifestations of the "long COVID-19" syndrome and to correlate them to abnormalities/signs on cerebral perfusion scintigraphy. Furthermore, the investigators aim to determine and validate a specific imaging biomarker of post-COVID-19 encephalopathy.
The secondary objective of this study is to determine the best therapeutic modality to treat and improve prognosis of patients with "long COVID-19" syndrome with defined central nervous system impairment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long Covid19 patient group | Experimental | Diagnostic Test: Perfusion brain scintigraphy imagingPatients with Long Covid19 undergoing perfusion brain scintigraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Physically and mentally able to fill out questionnaires;
- Suspicion and/or confirmation of COVID-19 infection, managed on an out- or inpatient (COVID-19 ward or ICU) basis;
- Residual symptoms at 8 weeks or more after initial SARS-CoV-2 infection.
Key exclusion criteria (2 listed)
- Diagnosed with a neurological syndrome e.g. Parkinson disease, Alzheimer disease, … before SARS-CoV-2 infection;
- Known Dementia or mild cognitive impairment before SARS-CoV-2.
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 |
|---|---|---|
| Perfusion brain scintigraphy imagingThe cerebral perfusion scintigraphy via a SPECT examination aims to analyze the cerebral blood flow and detect possible lesions or inflammations. | Diagnostic test | Long Covid19 patient group |
Primary outcome
Difference (1 year versus baseline) in the distribution of hypo-perfused areas in the brain as assessed by cerebral perfusion scintigraphy.
Time frame: 1 year
SPECT data were acquired using a standardized protocol. For focal abnormalities of increased or decreased uptake, the anatomical location was described.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
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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.
Marie Dominique Gazagnes principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfusion brain scintigraphy imaging in people with Long Covid19, run by Brugmann University Hospital at 1 site in Belgium.
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 2 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 8 Aug 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 Belgium. 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?
Contact Marie Dominique Gazagnes (3224773462, MarieDominique.GAZAGNES@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference (1 year versus baseline) in the distribution of hypo-perfused areas in the brain as assessed by cerebral perfusion scintigraphy. (time frame: 1 year). 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 8 Aug 2022.