COVID-19 U07.1
Conditions
Interventions
Group 1: Nasal/throat swab, blood sample, questionnaire
Sponsors
Zentrum für Infektionskrankheiten
Eligibility
Sex/Gender
All
Age
1 Years to 10 Years
Inclusion criteria
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 Part C (Amendment May 18, 2021): As much as possible, all subjects examined from study part B should be included in part C. • Participants in part B from a household consisting of at least 1 adult and at least one child <18 years (at the time of participation in part B) and with at least one member with a SARS-CoV-2 infection with or, which has been proven by RT-PCR without COVID-19 disease • Participants are not in quarantine due to renewed SARS-CoV-2 infection or suspected infection • Written consent to the study has been obtained
Exclusion criteria
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 Part C (Amendment 18.05.2021): - Lack of consent for child/youth or adults - Insufficient knowledge of German to understand the study information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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? Part C: How has the state of health of the participants examined in Part B developed and are there differenc | — |
Secondary
| Measure | Time frame |
|---|---|
| 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? Part C: How great is the interindividual variability or how stable is the ACE2 enzyme activity compared to the time of the investigation in part B(12 months previously) and are there differences in subgroups depending on the antibody response to SARS-CoV-2, the severity and symptoms of the initial SARS-CoV -2 Infection and health status over time, age, gender, household affiliation, previous illnesses and medication taken? | — |
Countries
Germany
Contacts
Public ContactGeorg Friedrich Hoffmann
Zentrum für Kinder- und JugendmedizinPaedKliPS
Outcome results
None listed