Official Title
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
Brief Summary

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

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.

Unknown status
SARS-CoV-2
COVID19
Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: 18 Years
Countries
Germany
Locations

Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf
NCT Number
Keywords
Pediatric
Children
Observational
antibody
PCR
immunology
metabolomics
Household
MeSH Terms
COVID-19