COVID-19 Child Health Investigation of Latent Disease in Hamburg

• Conditions: SARS-CoV-2; Covid19

• Registration Number: NCT04534608
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2020-05-11
• Primary Completion: 2020-06-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-01
• Last Update Posted: 2020-09-01
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute infection by SARS-CoV-2	6 weeks	Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany