COVID-19 Child Health Investigation of Latent Disease in Hamburg

Study Overview
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Brief Summary
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The study measures infection rates and the presence of antibodies for SARS-CoV-2 (COVID-19) among in- and outpatients of all pediatric hospitals, as well as volunteers aged 0 to 18 years in Hamburg, Germany. Participants with a positive nasopharyngeal swab PCR or a positive antibody test enter the Follow-up phase of 6 months. The follow up includes a PCR and antibody testing of all household contacts at 0, 3 and 6 months, as well as laboratory testing of children to identify immunological, metabolic and genetic risk factors for infection and clinical outcome.

Detailed Description
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The study is divided into a Screening phase and a Follow-up phase. In the Screening phase, an obligatory polymerase chain reaction (PCR) in the nasopharyngeal swab and an optional serum antibody testing are carried out for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An obligatory standardized questionnaire is used to evaluate symptoms and contacts, medical history and underlying conditions and the psychological effects of the Coronavirus disease 2019 (COVID-19) pandemic, as well as its effects on individual access to medical care. Children with a positive nasopharyngeal swab or antibody test, as well as their household contacts aged 0 to 18 years enter the Follow-up phase. During the Follow-up phase, blood and urine samples are taken from children for immunological analysis, HLA typing and untargeted metabolomics, enabling a broad analysis of the adaptive and innate immune response to SARS-CoV-2, as well as metabolic and genetic risk factors for infection and disease compared to age and sex-matched healthy controls. Furthermore, a repeated swab and antibody testing at 0, 3 and 6 months for children and adult household contacts is carried out to analyse household transmission of SARS-CoV-2 in children and adults and the persistence of antibodies.

Official Title
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Prevalence of Infection and Seroconversion and the Clinical Course of the Novel Coronavirus SARS-CoV-2 Infection in Children Between 0 to 18 Years of Age in Hamburg and Surroundings

Conditions
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SARS-CoV-2, Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children or Teenagers aged 0-18 years Patient in one of the participating centers or volunteer in the central C19.CHILD Study Clinic Informed consent from parents or guardians. Informed consent from children >7 years (unless not capable) Exclusion Criteria: Prematurity <37 weeks of gestation Informed consent of parents and guardians not possible in spoken word or otherwise Informed consent not given

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic children w/out an underlying condition<br> | |
| Asymptomatic children with underlying condition(s)<br> | |
| Children with COVID-19 symptoms w/out an underlying condition<br> | |
| Children with COVID-19 symptoms with underlying condition(s)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute infection by SARS-CoV-2 | Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion for SARS-CoV-2 | Detection of antibodies against SARS-CoV-2 in serum | 6 months | 
| Immune phenotyping | Analysis of the innate and adaptive immune system by flow cytometry | 6 months | 
| HLA Typing | HLA typing by sequencing to identify protective- and risk constellations | 6 months | 
| Matabolomics | Untargeted metabolomics in urine and plasma | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, children, observational, antibody, PCR, immunology, metabolomics, household