Investigating COVID-19 effects in children
Investigation of Prognostic Biomarkers, Host Factors and Viral Factors for COVID-19 Associated Encephalopathy/Encephalitis and Multi-systemic Inflammatory Syndrome in Children
This study is trying to learn more about how COVID-19 affects children, especially those with serious conditions like encephalitis or MIS-C, by looking at their symptoms and test results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | Tocilizumab, immunotherapy |
| Locations | 1 site (Taipei, Chung Cheng District) |
| Trial ID | NCT05576714 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify prognostic biomarkers, host genetic factors, and viral factors associated with COVID-19 in children, particularly focusing on COVID-19-associated encephalitis and multisystem inflammatory syndrome in children (MIS-C). Pediatricians will enroll hospitalized children under 18 years old who have tested positive for SARS-CoV-2 and exhibit symptoms of encephalitis or MIS-C. Clinical assessments, lab findings, and outcomes will be collected to better understand the severity and implications of these conditions. The study seeks to enhance knowledge of the immunopathogenesis and viral pathogenesis related to COVID-19 in the pediatric population.
Who should consider this trial
Good fit: Ideal candidates are hospitalized children under 18 years old with a positive SARS-CoV-2 test and clinical signs of encephalitis or MIS-C.
Not a fit: Patients who do not have COVID-19 or those over 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools and treatment strategies for children affected by severe COVID-19 complications.
How similar studies have performed: Other studies have indicated neurological complications in children with COVID-19, suggesting that this investigation builds on existing knowledge rather than being entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age less than 18 years old. 2. A positive SARS-CoV-2 test result (reverse transcriptase-polymerase chain reaction and/or antibody)。 3. Hospitalized children. 4. Clinical diagnostic criteria for encephalitis. Major criteria: 1). Altered mental status greater than 24 hours without alternative cause identified Minor criteria: need at least 2 minor criteria for encephalitis 1. Fever 2. Seizures 3. Focal neurologic signs 4. CSF: pleocytosis 5. EEG: abnormal slow background or epileptiform discharge 6. Neuroimaging: abnormal brain inflammation on MRI \*\*\*\*\*Major+2 minor: possible encephalitis; Major+3 minor: probable encephalitis; Brain biopsy: confirmed encephalitis The following 6 criteria for MIS-C have to be met: age 0 to 19 years, fever for ≥3 days, clinical signs of multisystem involvement (at least 2 systems), elevated markers of inflammation (e.g., CRP, procalcitonin or ferritin), evidence of SARS-CoV-2 infection and no other obvious microbial cause of inflammation. Exclusion Criteria: 1. Age more than 18 years old 2. Previous history of encephalopathy, acute encephalopathy caused by other etiology, not COVID-19, development delay, autism, ADHD, epilepsy and febrile seizure 3. Non-hospitalized children
Where this trial is running
Taipei, Chung Cheng District
- National Taiwan University Hospital — Taipei, Chung Cheng District, Taiwan (Recruiting)
Study contacts
- Study coordinator: Tsui-Yien Fan, RA
- Email: twffccy@gmail.com
- Phone: +886 2312 3456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.