COVID-19 Child Health Investigation of Latent Disease in Hamburg

NCT04534608 | Unknown DMC

• 1 other identifier: PV7336
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; Covid19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Acute infection by SARS-CoV-2

  Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab

  6 weeks

Secondary Outcomes (4)

• Seroconversion for SARS-CoV-2

  6 months

• Immune phenotyping

  6 months

• HLA Typing

  6 months

• Matabolomics

  6 months

Study Arms (4)

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)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Prematurity \<37 weeks of gestation
• Informed consent of parents and guardians not possible in spoken word or otherwise
• Informed consent not given

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Altona Children's Hospital: collaborator
• Wilhelmstift Children´s Hospital: collaborator
• Helios Mariahilf Klinik Hamburg: collaborator
• Asklepios Klinik Nord - Heidberg: collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Links

• Universitätsklinikum Hamburg-Eppendorf, Department of Pediatrics Homepage

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ania C Muntau, Professor

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Soeren W Gersting, Professor

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Thomas Mir, Professor

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 1, 2020
• Study Start: May 11, 2020
• Primary Completion: June 30, 2020
• Study Completion: March 31, 2021
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

DE (1)