U07.1
Conditions
Interventions
Group 1: Triple follow-up of index persons of the Gangelt register based on the "COVID-19 Case Cluster Study" (high prevalence region Heinsberg), as well as household or family members: Collection of
Sponsors
Institut für VirologieUniversitätklinikum Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consenting subjects who agree to participate in the study, regardless of age and acute or previous COVID-19 infection Registered residents of the defined municipalities, either: - Selection based on the "COVID-19 Case Cluster Study" (high prevalence Heinsberg district), or - randomly selected index persons by the municipal administration of Rheinbach (low-prevalence region) from the population registration data regardless of age and regardless of an acute or previous COVID-19 infection, as well as their household members
Exclusion criteria
Exclusion criteria: Refusal of informed consent. Contraindication for the described specimen collection methods (venipuncture or capillary blood collection via fingertip or throat swab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the prevalence of SARS/CoV-2 positive individuals in the study populations, defined as the number of participants with positive laboratory results (from at least one of the sample media taken in the study; the IgA value is excluded here because this test from the company Euroimmun has too low sensitivity and specificity) divided by the total number of study participants in the study period as well as the increase in new infections in the population of the already SARS-CoV-2 IgG/total antibody/PCR positive and the previously SARS-CoV-2 IgG/total antibody/PCR negative population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: (i) the "level of infestation", defined as the sum of a. prevalent participants and b. healthy participants with positive laboratory results from previous study phase with currently measured negative laboratory results in the study, divided by the total number of study participants (ii) the rate of infection incidence, defined as the number of participants with new positive laboratory findings (in the study) divided by the total number of study participants and per time interval between measurements (iii) the rate of reinfection as the proportion of participants with a repeat positive results in the case of a previous positive result, (iv) the severity of the infection, assessed by the need for medical treatment (graded: at home, repeated medical contact, hospitalization, intensive care). As an approximation, an increasing severity of infection with an increased number of symptoms is read. (v) Type, number and duration of persistent impairments that occurred after infection. (vi) associations of the above measures with the symptoms recorded in the questionnaire, (vii) the associations of the above measures with the personal and behavioral factors recorded in the questionnaire (viii) The vaccination rate, or the determination of the vaccination status of participants based on the following combinations of findings: - positive IgG test and negative total antibody test is defined as vaccinated and not recovered, - positive IgG test and positive total antibody test is defined as recovered or recovered and vaccinated if confirmation of vaccination status is available. | — |
Countries
Germany
Contacts
Public ContactHendrik Streeck
Institut für VirologieUniversitätklinikum Bonn
Outcome results
None listed