Trial document




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  DRKS00021521

Trial Description

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Title

Prevalence of COVID-19 in Children in Baden-Württemberg

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Trial Acronym

COVID-19 BaWü

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URL of the Trial

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Brief Summary in Lay Language

In the context of the COVID-19 pandemic, schools, kindergartens and day-care centres were closed. According to data available to date from various countries, severe courses of illness with COVID-19 in children are fortunately very rare. There are no data for Germany yet.
We want to investigate to what extent children and parents in Baden-Württemberg have been infected with COVID-19 and to what extent they would be exposed to dangers when schools, kindergartens and day-care centres reopen. We also want to investigate the proportion of adults and children who have had an infection. We want to find out if there are age subgroups within the group of children of 1 and 10 years of age regarding the infection rate. We also want to investigate whether the parents' occupation has an influence on the risk of infection and whether the living situation has an influence on the transmission rate of COVID-19.
One child between 1 and 10 years and one parent living in 2000 households in Baden-Württemberg will be screened for COVID-19.

Part B (Amendment 08.05.2020):
In addition, the study will examine how many children and adolescents have developed antibodies against the novel coronavirus (SARS-CoV-2) compared to adults from the same household. By measuring the concentration of a certain protein in the blood (ACE2), it is also investigated whether the concentration of this protein is related to the risk of infection and the severity of the disease.

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Brief Summary in Scientific Language

In the context of the COVID-19 pandemic, schools, kindergartens and day-care centres were closed. According to data available to date from various countries, severe courses of illness with COVID-19 in children are rare. No data are available for Germany to date on the extent to which children have already been infected with COVID-19. Previously published studies on COVID-19 showed that children with COVID-19 infection often have asymptomatic courses or the symptoms are usually only mild (Lu et al. 2020, Wu JT et al. 2020.). The actual prevalence of infection in children aged 1-10 years in Germany can currently only be roughly estimated and refers mainly to clearly symptomatic patients. A recently published population-based study from Iceland reported that children under 10 years of age were significantly less likely to be positive/infected with COVID-19 than adolescents and adults (Gudbjartsson et al 2020). This is supported by a household study conducted in Wuhan and Shanghai, which concludes that SARS-CoV-2 is transmitted less frequently to children between 0 and 14 years of age than to adults (Zhang et al., 2020). Overall, however, there is still very little data available worldwide on this issue.
Therefore, the role that children play in the transmission of SARS-CoV-2 is largely unclear. Based on current knowledge, it can be assumed that children who have already gone through the infection unnoticed develop SARS-CoV-2 antibodies and thus immunity, at least temporarily. Furthermore, it can be assumed that these seropositive children have a lower risk of infection for other persons/children than seronegative children when schools, kindergartens and KITAs reopen.
In a cross-sectional study (Part A), one child between 1 and 10 years of age and one parent from each of approximately 3000 households in Baden-Württemberg will be screened for COVID-19 (PCR from nasal/pharyngeal swab and determination of antibodies in the blood).

Since the point prevalence of SARS-CoV-2 infection is currently very low in Baden-Württemberg, this cross-sectional study alone cannot provide a reliable answer to the main target criterion for the seroprevalence of SARS-CoV-2 antibodies in children and adolescents compared to adults living in the same household. Part B (Amendment 08.05.2020)of the study will therefore examine a second study collective of households, of which at least one member of a household in which children and/or adolescents live has a proven SARS-CoV-2 infection with or without COVID-19 disease. Part B of the study will also determine ACE2 serum concentrations as a possible biomarker for SARS-CoV-2 infection with or without COVID-19 disease. Circulating ACE2 is the extracellular domain of transmembrane ACE2 as a cellular receptor for SARS-CoV-2. Children and women have a significantly higher ACE2 serum concentration than men. Therefore, it has been hypothesized that circulating ACE2, like a neutralizing antibody, reduces the binding of SARS-CoV-2 to its target cells and thus prevents SARS-CoV-2 infection with or without COVID-19 disease (Ciaglia et al, 2020).

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021521
  •   2020/04/22
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  •   yes
  •   Approved
  •   S-294/2020, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
  •   COVID-19
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Interventions/Observational Groups

  •   Nasal/throat swab, blood sample, color sheet
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   0
  •   N/A
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Primary Outcome

Part A:
What is the rate of SARS-CoV2 RNA positive children aged 1-10 years and one parent in a population-based sample in Baden-Württemberg?
What is the seroprevalence of SARS-CoV-2 antibodies in the collective mentioned under 1.
Are there age subgroups within the children of 1 and 10 years of age regarding infection rate?

Part B:
A nasal/pharyngeal swab and a blood sample (2-3 ml blood) are taken from the child and the accompanying parent to determine SARS-CoV2 RNA in the nasal/pharyngeal swab and SARS-CoV2 antibodies in the blood. The result will be communicated to the participants afterwards.
The participants will receive a questionnaire in which, among other things, their living situation, occupation, age and chronic illness will be assessed. Parents' chronic illnesses will be asked. Concerning the children, chronic illnesses, attendance of day-care centers, kindergarten, elementary school, since when the children have been in home care, or whether they have continued to attend KITAs or kindergartens or after-school care as part of emergency care, and whether there has been contact with a person with proven COVID-19 infection or whether SARS-CoV2 has already been detected in the participants themselves. Health problems (fever, cough, "cold", diarrhoea) current or in the last 4 weeks are asked for children and the participating parent.

What is the seroprevalence of SARS-CoV-2 antibodies in children and adolescents compared to adults from the same household with at least one index patient with a proven SARS-CoV-2 infection (positive PCR test) with or without COVID-19 disease?
Are there age-dependent subgroups within the children and adolescents aged 0 and 17 years with regard to the infection and disease rate?
Is the circulating ACE2 serum concentration as a biomarker associated with SARS-CoV-2 infection with or without COVID-19 disease or its severity?

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Secondary Outcome

Part A:
To what extent is SARS-CoV2 transmitted to children between 1 and 10 years of age when they come into contact with an infected parent?
To what extent is SARS-CoV2 transmitted to one parent in contact with an infected child between 1 and 10 years of age? What is the rate of intrafamily transmission?
What is the proportion of parents or children who have been diagnosed with antibodies against SARS-CoV2 but who have not developed symptoms?
Does the living situation have an influence on the transmission rate between parent and child?
Does the professional environment of the parents influence the family risk of infection?
Does the family size influence the familial risk of infection?

Part B:
How high is the proportion of adults or children and adolescents within a household who were found to have antibodies against SARS-CoV-2 but did not develop symptoms compared to persons living in the same household who were symptomatic?
Does household size have an influence on the transmission rate between adults and children or adolescents within a household?
Does the professional environment of the adults or adolescents or the school or daycare environment of the child influence the risk of infection within a household?
Does the size of the household influence the risk of infection within a household?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/22
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   10   Years
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Additional Inclusion Criteria

Part A:
- Children (male or female) aged 1 to 10 years
- One parent (male or female) without age limit
- Child and parent living in the same household
- Resident in Baden-Württemberg
- Written consent to the study has been obtained

Part B (Amendment 08.05.2020):
If possible, all members of a household in which at least one child or adolescent aged 0-17 years should be included in this study. They must meet the following inclusion criteria:
- Household community consisting of at least one adult and at least one child <18 years and with at least one member with SARS-CoV-2 infection detected by rt-PCR or antibody test, with or without COVID-19 disease
- Children and adolescents (male, female or various) aged 0 to 17 years (up to one day before their 18th birthday) living in the same household
- Adults ( no age limit, male, female or various) living in the same household as the children and adolescents
- Participants are no longer in quarantine due to SARS-CoV-2 infection
- Resident in Baden-Württemberg
- Written consent to the study has been obtained

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Exclusion Criteria

Part A:
- Severe congenital diseases (e.g. infantile cerebral palsy, severe congenital malformations)
- Congenital or acquired immunodeficiencies
- COVID-19 infection in the child or parents already proven before the study
- Lack of consent for child or parent

Part B (Amendment 08.05.2020):
- Lack of consent for child/youth or adults
- Insufficient knowledge of German to understand the study information

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Addresses

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    • Zentrum für Infektionskrankheiten
    • Mr.  Prof. Dr.  Hans-Georg  Kräusslich 
    • Im Neuenheimer Feld 324
    • 69120  Heidelberg
    • Germany
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    • Zentrum für Kinder- und JugendmedizinPaedKliPS
    • Mr.  Prof. Dr.  Georg Friedrich  Hoffmann 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Zentrum für Infektionskrankheiten
    • Mr.  Prof. Dr.  Hans-Georg  Kräusslich 
    • Im Neuenheimer Feld 324
    • 69120  Heidelberg
    • Germany
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    • Zentrum für Kinder- und JugendmedizinPaedKliPS
    • Mr.  Prof. Dr.  Georg Friedrich  Hoffmann 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Zentrum für Kinder- und JugendmedizinPaedKliPS
    • Mr.  Prof. Dr.  Georg Friedrich  Hoffmann 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Center for Chronic Immunodeficiency in the Center for Translational Cell Research (ZTZ)
    • Mr.  Prof. Dr.  Philipp  Henneke 
    • Breisacher Straße 115
    • 79106  Freiburg
    • Germany
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    • Ulm University Medical CenterDpt. of Pediatrics and Adolescent Medicine Ulm University Medical
    • Mr.  Prof. Dr.  Klaus-Michael  Debatin 
    • Eythstr. 24
    • 89075  Ulm
    • Germany
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    • Klinik für Kinder- und Jugendmedizin,Universitätsklinikum Tübingen
    • Ms.  Dr  Hanna  Renk 
    • Hoppe-Seyler-Str. 1-3
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Kinder- und JugendmedizinPaedKliPS
    • Mr.  Prof. Dr.  Georg Friedrich  Hoffmann 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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