COVID-19-Associated EncephalitisNCT05566392
Longterm Influence of Pediatric Long COVID Syndrome
An observational study of COVID-19-Associated Encephalitis and Long COVID, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19-Associated Encephalitis, Long COVID
- What is being tested?
- Brain MRI
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2022to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Aged between 6-18 years old pediatric patient diagnosed as COVID would be enrolled. The patient who had neuropsychiatric disorders would be excluded. We also enroll age- and gender-matched healthy participants for cross-over comparison
Who may be able to join
- Age 6-18 years old
- Has been diagnosed COVID-19 before
Who cannot join
- History of neuropsychiatric disorders
- Have some device not allowed for MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Children Hospital Pediatric Neurology Department
Taipei
Wang-Tso Lee, PHD, (886)2-23123456 ext. 71618, leeped@hotmail.com
About this study
Official title: Longterm Influence of Pediatric Long COVID Syndrome on the Neuropsychiatric Function, Social Function, Neuroimage, and Gut Microbiota
We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation
- Conditions
- COVID-19-Associated Encephalitis, Long COVID
- Being tested
- Brain MRI
- Keywords
- pediatric neurology, psychiatric evaluation, Long COVID syndrome, magnetic resonance image
- 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.
Brain MRIDiagnostic test
Also called Neuropsychiatric evaluation, Near infrared spectroscopy
Brain MRI including diffusion spectrum image, and functional MRI Interview with questionnaires for neuropsychiatric evaluation Near infrared spectroscopy and resting-state connectivity evaluation
| Study group | Role | What they receive |
|---|---|---|
| Coronavirus disease (COVID) | Pediatric patients who was diagnosed as COVID Receives: Diagnostic Test: Brain MRI | |
| Healthy | Pediatric participants who hadn't been diagnosed COVID before Receives: Diagnostic Test: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between COVID and healthy group
The neuroimage difference between COVID and healthy group and the correlation with neuropsychiatric evaluation
Measured: 1 years after enrollment for primary evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Oct 2022
- Primary completionOct 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19-Associated EncephalitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang-Tso Lee, PHD, Principal investigator, National Taiwan University Children Hospital Pediatric neurology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566392
- Sponsor's protocol ID
- 202208086RIND
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: according to our participant consent, the participant information will be stored as de-identification data
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Influence of Pediatric Long COVID Syndrome on the Neuropsychiatric Function, Social Function, Neuroimage, and Gut Microbiota
- ClinicalTrials.gov ID
- NCT05566392
- Acronym / sponsor ID
- 202208086RIND
- Conditions
- COVID-19-Associated Encephalitis, Long COVID
- Keywords
- pediatric neurology, psychiatric evaluation, Long COVID syndrome, magnetic resonance image
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Oct 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.
We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronavirus disease (COVID) | – | Diagnostic Test: Brain MRIPediatric patients who was diagnosed as COVID |
| Healthy | – | Diagnostic Test: Brain MRIPediatric participants who hadn't been diagnosed COVID before |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Aged between 6-18 years old pediatric patient diagnosed as COVID would be enrolled. The patient who had neuropsychiatric disorders would be excluded. We also enroll age- and gender-matched healthy participants for cross-over comparison
Key inclusion criteria (2 listed)
- Age 6-18 years old
- Has been diagnosed COVID-19 before
Key exclusion criteria (2 listed)
- History of neuropsychiatric disorders
- Have some device not allowed for MRI
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 |
|---|---|---|
| Brain MRIAlso: Neuropsychiatric evaluation, Near infrared spectroscopyBrain MRI including diffusion spectrum image, and functional MRI Interview with questionnaires for neuropsychiatric evaluation Near infrared spectroscopy and resting-state connectivity evaluation | Diagnostic test | Coronavirus disease (COVID), Healthy |
Primary outcome
Difference between COVID and healthy group
Time frame: 1 years after enrollment for primary evaluation
The neuroimage difference between COVID and healthy group and the correlation with neuropsychiatric evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No. according to our participant consent, the participant information will be stored as de-identification data
Related trials for COVID-19-Associated Encephalitis
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Post-Acute COVID-19 Syndrome, ME/CFS
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.
Wang-Tso Lee, PHD principal investigator
National Taiwan University Children Hospital Pediatric neurology department
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-Associated Encephalitis and Long COVID, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Aug 2024. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang-Tso Lee, PHD ((886)2-23123456 ext. 71618, leeped@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between COVID and healthy group (time frame: 1 years after enrollment for primary evaluation). 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 6 Aug 2024.