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| Name | Class |
|---|---|
| Altona Children's Hospital | OTHER |
| Wilhelmstift Children´s Hospital | UNKNOWN |
| Helios Mariahilf Klinik Hamburg | UNKNOWN |
| Asklepios Klinik Nord - Heidberg |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asymptomatic children w/out an underlying condition | |||
| Asymptomatic children with underlying condition(s) | |||
| Children with COVID-19 symptoms w/out an underlying condition | |||
| Children with COVID-19 symptoms with underlying condition(s) |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute infection by SARS-CoV-2 | Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Control Group:
A group of children tested negative for SARS-CoV-2 by PCR and antibody testing will be included as control group for the immunologic, metabolic and genetic follow up. This group is recruited from participants in group 2 and 3 (above).
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| Name | Affiliation | Role |
|---|---|---|
| Ania C Muntau, Professor | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Soeren W Gersting, Professor | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Thomas Mir, Professor | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
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| Label | URL |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf, Department of Pediatrics Homepage | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| UNKNOWN |
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| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |