Trial document





This trial has been registered retrospectively.
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  DRKS00022434

Trial Description

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Title

CorKid (COVID19/ SARS-CoV-2 seroconversion in kids)

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Trial Acronym

CorKid

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URL of the Trial

http://corkid.de

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Brief Summary in Lay Language

The first infections with a new corona virus (SARS-CoV-2) appeared in China at the end of 2019. Since then, this virus has spread all over the world and many people were infected very seriously. Not much is known about the course in children, also because the infection in children is often very mild and is therefore not recognized, but they can still be contagious.
CorKID is a study by the Bochum University Children's Hospital in collaboration with several pediatric practices in NRW, the Institute of Human Genetics and the Institute of Virology at the Ruhr University Bochum (RUB).
In a large study of over 3000 children and adolescents between ½ year and 18 years old (and their families), we want to investigate how infection with SARS-CoV-2 has already spread among children in Bochum, Herne and the surrounding area. For this purpose, we want to determine antibodies against SARS-CoV-2 in children who attend a pediatric practice for a preventive examination (U-Untersuchung). We also ask about previous infections and other diseases, as well as certain risk factors. This survey will be repeated in the following year. In addition, there is also the possibility of antibody testing for siblings and parents.

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Brief Summary in Scientific Language

Despite high total number of confirmed COVID-19 cases globally the existing data on SARS-CoV-2/COVID-19 specifically in children and adolescents remain very limited. Data from Chinese centres and from a Spanish cohort suggests that children in general are less severely affected than adults >60 years, but most of the published data focus on number of cases and case fatality rates of hospitalized children. Probably, the majority of SARS-CoV-2 infections in children remain undetected because of the lack of clinical symptoms. The rate of seroconversion in this population is therefore very hard to estimate but can be assessed by measuring SARS-CoV-2 IgM or IgA and IgG antibody concentrations 2-4 weeks after the infection.
We assume that the percentage of children with COVID-19 seroconversion rises over the course of the study in an unselected paediatric population indicating increasing immunity against COVID-19.
We aim to evaluate the rate of seroconversion at defined time points (U-Untersuchungen) and to follow- up these children during their next medical screenings. U- Untersuchungen are defined medical screening examinations scheduled from birth to the age of 17 years. Attendance rates are high (80-90%) and attendance is supervised by the Ministry of Health and the Youth Welfare Offices.
The Ruhr region is densely populated but has not been a hot spot of the SARS-CoV-2 pandemic. Therefore, we presume that the percentage of 10-20% will be infected by the end of study period.
Additionally, we want to determine the rate of seroconversion in the parents especially in the mothers in order to assess the percentage of concordance and discordance in seroconversion.
ACE2 inhibitors have been reported to increase the risk of severe COVID-19 infection and ACE2 polymorphism have been associated with decreased COVID-19 immune response. We are planning to investigate the distribution of polymorphism in the ACE2 receptor as well as 3 SNPs (rs2070788, rs9974589, rs7364083) associated with higher TMPRSS2 expression.
As a post hoc analysis initiated pilot study we would like to assess the single-cell RNA expression of ACE2 and TMPRSS2 in the nasal mucosa as described by Wu et al. in subgroups of children and mothers, e.g. discordant pairs with seropositive mothers and seronegative children.
Follow-up questionnaires will be performed at 3, 6 and 12 months. In addition to acute infections the frequency and severity of respiratory symptoms in the follow- up period will be recorded. Transient or persistent bronchial hyperresponsiveness has been described after viral airway infections in children, but has not been evaluated yet after SARS- CoV-2 infection. Additional SARS- CoV-2 antibody testing will be offered to initially seronegative participants.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

All evaluations as well as selected data are made available to the BMBF and others

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Organizational Data

  •   DRKS00022434
  •   2020/08/07
  •   [---]*
  •   yes
  •   Approved
  •   20-6927, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Children and adolescents attending for a medical check-up in selected pediatric practices receive a questionnaire on e.g. risk of infection and clinical symptoms in the last 3 months. Then they are tested for Sars-CoV-2 antibodies. Follow-up after 3, 6 and 12 months (renewed questionnaire and, if necessary, renewed antibody determination)
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

In children and adolescents, seroconversion rate for SARS-CoV-2 will be detectable in 10-20% within the observation period of 6 months

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Secondary Outcome

In children and adolescents, there are risk factors such as certain polymorphisms in the ACE2 receptor or pulmonary pre-existing conditions for more severe courses of a COVID-19 infections.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/06/08
  •   3000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Months
  •   18   Years
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Additional Inclusion Criteria

- 6 months– 18 years
- Patients who present in the practice for routine medical screening (U-Untersuchungen)
- signed consent
- Mothers or other family members (fathers, siblings) of the subjects primarily included (of all ages from 6 months)

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Exclusion Criteria

no consent to the study

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Addresses

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    • Universitätskinderklinik im St.-Josef Hospital Klinikum der Ruhr-Universität-Bochum
    • Mr.  Prof.  Thomas  Lücke 
    • Alexandrinenstr. 5
    • 44791  Bochum
    • Germany
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    • Universitätskinderklinik im St. Josef-HospitalKlinikum der Ruhr-Universität-Bochum
    • Mr.  Prof. Dr.   Thomas  Lücke 
    • Alexandrinenstr. 5
    • 44791  Bochum
    • Germany
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    • Universitätskinderklinik Bochum
    • Corkid  Studienteam 
    • Alexandrinenstr. 5
    • 44791  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfprotokoll
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* This entry means the parameter is not applicable or has not been set.