An observational study in SARS-CoV-2 and Covid19, sponsored by Universitätsklinikum Hamburg-Eppendorf. Status unknown at 1 site in Germany. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-01.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 6,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
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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).
Exclusion Criteria:
Acute infection by SARS-CoV-2
Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab
Time frame: 6 weeks
Seroconversion for SARS-CoV-2
Detection of antibodies against SARS-CoV-2 in serum
Time frame: 6 months
Immune phenotyping
Analysis of the innate and adaptive immune system by flow cytometry
Time frame: 6 months
HLA Typing
HLA typing by sequencing to identify protective- and risk constellations
Time frame: 6 months
Matabolomics
Untargeted metabolomics in urine and plasma
Time frame: 6 months
Plan to share: Undecided
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf