NCT04534608

COVID-19 Child Health Investigation of Latent Disease in Hamburg

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2
• Covid19

Timeline

• Start date: 2020-05-11
• Primary completion: 2020-06-30
• Completion: 2021-03-31
• First posted: 2020-09-01
• Last updated: 2020-09-01

Locations

1 site across 1 country: Germany