COVID-19 Child Health Investigation of Latent Disease in Hamburg (C19CHILD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; SARS-CoV-2

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 Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. In- and outpatients aged 0 to 18 years of all pediatric hospitals in Hamburg, Germany
2. Healthy children aged 0 to 18 years as volunteers
3. Participants of other studies or their children (Prenatal Investigation of Children's Health - PRINCE Study, Hamburg City Health Study)
4. Children, who are household contacts of SARS-CoV-2 positive study participants will directly enter the Follow-up phase

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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Asymptomatic children w/out an underlying condition
Asymptomatic children with underlying condition(s)
Children with COVID-19 symptoms w/out an underlying condition
Children with COVID-19 symptoms with underlying condition(s)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Altona Children's Hospital; Wilhelmstift Children´s Hospital; Helios Mariahilf Klinik Hamburg; Asklepios Klinik Nord - Heidberg
• Investigators: Principal Investigator: Ania C Muntau, Professor, Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Soeren W Gersting, Professor, Universitätsklinikum Hamburg-Eppendorf; Principal Investigator: Thomas Mir, Professor, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

Helpful Links

• Study Homepage
• Universitätsklinikum Hamburg-Eppendorf, Department of Pediatrics Homepage

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pediatric; children; antibody; PCR; observational; metabolomics; immunology; household
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PV7336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No