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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT04534608

Collaborator

Altona Children's Hospital (Other), Wilhelmstift Children´s Hospital (Other), Helios Mariahilf Klinik Hamburg (Other), Asklepios Klinik Nord - Heidberg (Other)

6,000

Enrollment

Location

10.6

Anticipated Duration (Months)

563.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Covid19

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 Design

Study Type:

Observational

Actual Enrollment :

6000 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 11, 2020

Actual Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Acute infection by SARS-CoV-2 [6 weeks]
Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf
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