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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04534608

Acronym

C19CHILD

Enrollment

6000

Registered

2020-09-01

Start date

2020-05-11

Completion date

2021-03-31

Last updated

2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV-2

Keywords

pediatric, children, observational, antibody, PCR, immunology, metabolomics, household

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.

Interventions

None listed

Study design

Observational model

FAMILY_BASED

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Acute infection by SARS-CoV-2	6 weeks	Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab

Secondary

Measure	Time frame	Description
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

Countries

Germany

Outcome results