COVID-19 Child Health Investigation of Latent Disease in Hamburg

Covid19 Clinical Trial

— C19CHILD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04534608
• Other study ID #: PV7336
• Status: Active, not recruiting
• Start date: May 11, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: March 31, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• SARS-CoV-2

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (5)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Altona Children's Hospital, Asklepios Klinik Nord - Heidberg, Helios Mariahilf Klinik Hamburg, Wilhelmstift Children´s Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute infection by SARS-CoV-2	Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab	6 weeks
Secondary	Seroconversion for SARS-CoV-2	Detection of antibodies against SARS-CoV-2 in serum	6 months
Secondary	Immune phenotyping	Analysis of the innate and adaptive immune system by flow cytometry	6 months
Secondary	HLA Typing	HLA typing by sequencing to identify protective- and risk constellations	6 months
Secondary	Matabolomics	Untargeted metabolomics in urine and plasma	6 months

External Links

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