COVID-19 Child Health Investigation of Latent Disease in Hamburg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)

NCT04581148

SARS-Cov2

UNKNOWN

Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19

NCT04355533

COVID-19 Infection

COMPLETED NA

Post COVID-19 Complications in Children

NCT05745974

Post COVID-19 Condition

UNKNOWN

Prevalence of Antibodies Against SARS-CoV-2 Virus That Causes COVID-19 in Tübingen Children

NCT04581889

Severe Acute Respiratory Syndrome

COMPLETED

Seroprevalence and Immunoprotection Against COVID-19 in Parisian Children

NCT04490811

COVID-19

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asymptomatic children w/out an underlying condition

No interventions assigned to this group

Asymptomatic children with underlying condition(s)

No interventions assigned to this group

Children with COVID-19 symptoms w/out an underlying condition

No interventions assigned to this group

Children with COVID-19 symptoms with underlying condition(s)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes