SARS-CoV-2C19CHILDNCT04534608
COVID-19 Child Health Investigation of Latent Disease in Hamburg
An observational study of SARS-CoV-2 and Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Covid19
- How many people
- 6,000 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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)
Who cannot join
- Prematurity <37 weeks of gestation
- Informed consent of parents and guardians not possible in spoken word or otherwise
- Informed consent not given
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- SARS-CoV-2, Covid19
- Keywords
- pediatric, children, observational, antibody, PCR, immunology, metabolomics, household
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic children w/out an underlying condition | Not described | |
| Asymptomatic children with underlying condition(s) | Not described | |
| Children with COVID-19 symptoms w/out an underlying condition | Not described | |
| Children with COVID-19 symptoms with underlying condition(s) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute infection by SARS-CoV-2
Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab
Measured: 6 weeks
Secondary outcomes (4)
Seroconversion for SARS-CoV-2
Detection of antibodies against SARS-CoV-2 in serum
Measured: 6 months
Immune phenotyping
Analysis of the innate and adaptive immune system by flow cytometry
Measured: 6 months
HLA Typing
HLA typing by sequencing to identify protective- and risk constellations
Measured: 6 months
Matabolomics
Untargeted metabolomics in urine and plasma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start11 May 2020
- Primary completion30 Jun 2020
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Altona Children's Hospital, Wilhelmstift Children´s Hospital, Helios Mariahilf Klinik Hamburg, Asklepios Klinik Nord - Heidberg
- Responsible party
- Principal investigator, Ania C. Muntau, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Ania C Muntau, Professor, Principal investigator, Universitätsklinikum Hamburg-EppendorfSoeren W Gersting, Professor, Principal investigator, Universitätsklinikum Hamburg-EppendorfThomas Mir, Professor, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534608
- Sponsor's protocol ID
- PV7336
- Acronym
- C19CHILD
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04534608
- Acronym / sponsor ID
- C19CHILD / PV7336
- Conditions
- SARS-CoV-2, Covid19
- Keywords
- pediatric, children, observational, antibody, PCR, immunology, metabolomics, household
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Altona Children's Hospital, Wilhelmstift Children´s Hospital, Helios Mariahilf Klinik Hamburg, Asklepios Klinik Nord - Heidberg
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Prematurity <37 weeks of gestation
- Informed consent of parents and guardians not possible in spoken word or otherwise
- Informed consent not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute infection by SARS-CoV-2
Time frame: 6 weeks
Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab
4 secondary outcomes
Seroconversion for SARS-CoV-2
Time frame: 6 months
Immune phenotyping
Time frame: 6 months
HLA Typing
Time frame: 6 months
Matabolomics
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Universitätsklinikum Hamburg-Eppendorf, Department of Pediatrics HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ania C Muntau, Professor principal investigator
Universitätsklinikum Hamburg-Eppendorf
Soeren W Gersting, Professor principal investigator
Universitätsklinikum Hamburg-Eppendorf
Thomas Mir, Professor principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute infection by SARS-CoV-2 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.