NCT05582512 Clinical Characteristics and Long Term Impact on Pediatric COVID-19 in Taiwan
| NCT ID | NCT05582512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Long Covid19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2022-07-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project will study severe COVID-19 related factors, host genes, biomarkers, and prognosis of severe encephalitis in children, and conduct: 1. Retrospective clinical analysis of children with COVID-19, to analyze the clinical manifestations of children with new crown infection, and to find the relevant factors of severe disease. 2. Prospective acceptance in the acute phase: mainly to understand the correlation between the interaction of host factors, viruses and microorganisms and the severity. 3. Children's long COVID-19 Tracking Team An integrated outpatient clinic for "Long COVID-19 Syndrome in Children" will be established to conduct systematic tracking of body, lung function, nerves and psychology. Children with neurological complications or other confirmed diagnoses will undergo physical, neurological, pulmonary function and brain MRI and neurophysiological examinations, sleep examinations, and conduct psychiatric clinical diagnostic interviews to establish a psychiatric diagnosis. Status and family social function, the intelligence development status was examined by intelligence test, and cognitive function was measured by neuropsychological test. Understand the microbial phase, immune function and incidence of allergic diseases after long-term new coronavirus infection. 4. Seroepidemiological Study Group Exploring the seroepidemiology of different groups of health care workers and non-health care workers will allow us to better understand the magnitude of natural infection among children and age groups in the community and the infection profile of health care workers during this period. This trial includes multiple groups of prospective cases to explore the impact of the new coronavirus on children and the mechanism of severe illness, and integrates various specialties and branches of the Children's Hospital to conduct a summary trial, which is expected to understand children's new crown and community epidemiology, children infected with new crown Clinical manifestations of the virus, risk factors and effects on various systems, combined with host microbiome, immune function analysis and whole-exome sequencing, to improve the detection of new coronavirus (including long-term new coronary syndrome and pediatric multisystem inflammatory syndrome). Mechanisms of host factors and interactions with microbes to improve outcomes and severe incidence in children.
Eligibility Criteria
Inclusion Criteria: * COVID-19 positive cases Exclusion Criteria: 1. You have metal substances that cannot be removed or implanted, such as: braces, metal nails, artificial electronic ears, heartbeat pacemakers, etc. Because of the inability to perform brain MRI, it is not suitable to participate in this trial. 2. Have major physical diseases. 3. Sensory impairment, such as deafness. 4. Movement disorders, such as cerebral palsy. 5. Uncontrolled and stable epilepsy. 6. Pregnant women are not suitable to participate in this test. (If you are pregnant or not sure if you are pregnant, please let the researcher know in advance so that a pregnancy test can be performed). 7. Those who have suffered from hypoxia due to encephalitis or other reasons not caused by enterovirus infection are not suitable to participate in this test.
Contact & Investigator
Luna-Yin Chang, professor
STUDY CHAIR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05582512 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Long Covid19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05582512 currently recruiting?
Yes, NCT05582512 is actively recruiting participants. Contact the research team at twffccy@gmail.com for enrollment information.
Where is the NCT05582512 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05582512 clinical trial?
NCT05582512 is sponsored by National Taiwan University Hospital. The principal investigator is Luna-Yin Chang, professor at National Taiwan University Hospital. The trial plans to enroll 3,000 participants.
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