Clinical Characteristics and Long Term Impact on Pediatric COVID-19 in Taiwan

NCT05582512 | Recruiting

• 1 other identifier: 202206053RINC
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This project will study severe COVID-19 related factors, host genes, biomarkers, and prognosis of severe encephalitis in children, and conduct:

1. 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. 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. 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. 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.

Conditions

Long Covid19; COVID-19 Pneumonia; Multisystem Inflammatory Syndrome in Children

Keywords

COVID-19; long COVID; MIS-C

Outcome Measures

Primary Outcomes (3)

• risk factor and complication

  Clinical symptoms, for example: cough, Headache, rash......etc.

  over 3 months

• Multidimensional Fatigue Inventory, MFI)-20

  for long COVID-19 children and family

  one month

• seropositive rate of COVID-19

  Anti-SARS-CoV-2 ELISA assay

  one day

Study Arms (5)

Clinical Characteristics of pediatric COVID-19 by the retrospective research group

Analyze all clinically visible data of hospitalized children with COVID-19 infection (different virus strains), and then find the cause of severe disease and related risk factors for disease

Other: sequelae tracking

acute case receiving group (including children with multisystem inflammatory syndrome)

1. The correlation between the microbial flora of the respiratory tract and the central nervous system and the severity of SARS-CoV2 pneumonia and host immunity (host inflammatory biomarkers, antibody library/cell receptor library, chemokines, cytokines, cell-regulated immune responses, table Epitope mapping, host transcriptome studies) 2. To explore the correlation between the clinical manifestations of gastrointestinal tract and liver and SARS-CoV-2 infection and the analysis of gut microbiota 3. To analyze the host gene factors of COVID-19 patients. 4. To explore the changes of brain injury biomarkers (Biomarker) in acute and chronic phases, and to analyze the correlation with changes in brain structure and other clinical factors (e.g. severity of neurological symptoms)

Other: sequelae tracking

children's long COVID-19 tracking group

1. Clarify the incidence and persistent impact of COVID-19 symptoms in children through outpatient assessment, and further analyze the factors related to preventing the development of COVID-19. / Conduct long-term follow-up through brain MRI and neurophysiological examinations to explore the effects of COVID-19 infection on children brain structure and peripheral nerve function, and analyze the association of risk factors and other clinical symptoms. A psychiatric clinical diagnostic interview was also conducted to establish a psychiatric diagnosis. The emotional and behavioral assessment scale was used to fully evaluate the mental state and family social function. 2. To analyze the correlation between host genes and antibody repertoire/receptor repertoire, epitope mapping, microbial phase, and prognosis of severe COVID-19 patients

Other: sequelae tracking

seroepidemiological research group

Through the antibody test and the content of the questionnaire, we can better understand the epidemiology of the COVID-19. Including the proportion of asymptomatic infections, the scale of infection, the speed of transmission, etc. Vaccinated people can also learn about the speed of antibody decline

Other: sequelae tracking

healthy control group

Provide a sample of the normal population of the "Acute Reception Unit". To carry out respiratory microbial flora, host inflammatory biomarkers, antibody library/receptor library, chemokines, cytokines, cell-mediated immune responses, epitope mapping, brain MRI, neurophysiological examinations (neurophysiological examinations) Conduction, brain waves, sleep watch checks, etc.), brain injury biomarkers (Biomarker), healthy control group studies of host transcriptome

Other: sequelae tracking

Interventions

sequelae tracking OTHER

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 flora, immune function and incidence of allergic diseases after long-term COVID-19 infection

Clinical Characteristics of pediatric COVID-19 by the retrospective research group; acute case receiving group (including children with multisystem inflammatory syndrome); children's long COVID-19 tracking group; healthy control group; seroepidemiological research group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 positive cases younger than 18 years old

You may qualify if:

• COVID-19 positive cases

You may not qualify if:

• 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.
• Have major physical diseases.
• Sensory impairment, such as deafness.
• Movement disorders, such as cerebral palsy.
• Uncontrolled and stable epilepsy.
• 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).
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Chung Cheng District, 100, Taiwan

RECRUITING

Related Publications (30)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood, throat or nasopharyngeal swab, stool, sputum, BAL, CSF

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; pediatric multisystem inflammatory disease, COVID-19 related; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luna-Yin Chang, professor

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Tsui-Yien Fan, RA

CONTACT

+886 2312 3456; twffccy@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

TW (1)