Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04534608
Recruitment Status : Active, not recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
Altona Children's Hospital
Wilhelmstift Children´s Hospital
Helios Mariahilf Klinik Hamburg
Asklepios Klinik Nord - Heidberg
Information provided by (Responsible Party):
Ania C. Muntau, Universitätsklinikum Hamburg-Eppendorf

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : June 30, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Acute infection by SARS-CoV-2 [ Time Frame: 6 weeks ]
    Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab


Secondary Outcome Measures :
  1. Seroconversion for SARS-CoV-2 [ Time Frame: 6 months ]
    Detection of antibodies against SARS-CoV-2 in serum

  2. Immune phenotyping [ Time Frame: 6 months ]
    Analysis of the innate and adaptive immune system by flow cytometry

  3. HLA Typing [ Time Frame: 6 months ]
    HLA typing by sequencing to identify protective- and risk constellations

  4. Matabolomics [ Time Frame: 6 months ]
    Untargeted metabolomics in urine and plasma


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534608


Locations
Layout table for location information
Germany
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
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Ania C. Muntau, Medical Director, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04534608    
Other Study ID Numbers: PV7336
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ania C. Muntau, Universitätsklinikum Hamburg-Eppendorf:
pediatric
children
observational
antibody
 PCR
immunology
metabolomics
household
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases