Coronavirus disease 2019 (COVID-19) U07.1
Conditions
Interventions
Group 1: COALA is a daycare group/household-based study with a case-ascertained study design in the context of a COVID-19 outbreak in a daycare center. Included will be SARS-CoV-2 daycare index cases
Sponsors
Robert Koch-Institut
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for a daycare center: - Daycare center with current SARS-CoV-2 outbreak confirmed by health department. - Diagnosis of the daycare case was no more than 5 days ago at the time of contact. Household inclusion criteria: - One SARS-CoV-2 positive person from the Kita lives in the household (inclusion of other household members in the household cohort as well). Inclusion criteria for individuals: - Daycare children (at least 1 year old) or daycare workers who have currently tested positive for SARS-CoV-2. The entire household is then included (household cohort) if that person in the household is the primary case. - Individuals from Group 1 living in the same household as the individuals listed above (parents, partners, siblings, and others); - Daycare children or daycare workers who currently tested negative for SARS-CoV-2 but were exposed to the primary case (e.g., in the same daycare group). Here, only the individual him/herself is included (as part of the daycare cohort). - Presence of a written informed consent for study participation; in the case of the child: a written consent of the legal guardian or, in the case of an incapacitated person, the consent of his/her caregiver.
Exclusion criteria
Exclusion criteria: Participants younger than one-year old, children and adults without sufficient knowledge of the German language to understand the complex study information and the declaration of written informed consent and individuals with health substantial problems that does not allow any specimen collection (e.g., infection, swelling, injury) were excluded from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The secondary attack rate (SER, also called secondary infestation rate) is used as the primary endpoint of this study. It denotes the number of infected persons (secondary cases) divided by the number of persons exposed to the primary case. Follow-up cases will be identified via periodic PCR of swabs or Saliva samples performed on exposed individuals. Both the primary cases and exposed contacts can be stratified and evaluated by age (children, adults). | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcomes are: - serial interval: The serial interval refers to the period between the onset of symptomatology in the primary case and the onset of symptomatology in the secondary case. - mean viral excretion of the examined individuals: can be determined by PCR via the ct value and mapped in its longitudinal course. In this context, the question is examined, e.g, whether the infected persons also have a viral load in the oral-nasal region pre at which infectivity can be assumed. - Seroconversion rate: the proportion of individuals with SARS-CoV-2 antibodies among all those who had a positive PCR result for SARS-CoV-2 in the study (=acute infection) is calculated. - Symptom clearance and manifestation index. - Risk factors and protective factors that have a potential influence on susceptibility and progression of SARS-CoV-2 in children and adults. - Contextual factors of transmission dynamics in daycare centers. | — |
Countries
Germany
Contacts
Public ContactCoala-Studienteam
Robert Koch-Institut
Outcome results
None listed