Clinical trial NCT04521088: Epidemiological Analysis of Ambulant Patients in a COVID-19 Outpatient Clinic
Official title: Epidemiological Analysis of Ambulant Patients in a COVID-19 Outpatient Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 1316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all visitors of the outpatient clinic for COVID-19 since february 2020 in Solingen

Brief summary: There is insufficient knowledge about transmission routes and the effectiveness of general protective measures to prevent infection, such as the closure of schools or the wearing of mouthguards. This will be illustrated using the example of the COVID-19 outpatient clinic in Solingen and the positive COVID-19 tests registered there.

Another aspect we would like to address in this study is the number of COVID-19 tests performed against the background of political events or dramatic accumulations of COVID-19 cases in other parts of Germany or Europe. Do speeches by political leaders about the COVID-19 situation or a very strong regional spread of infection elsewhere have an impact on the frequency with which people react sensitively to suspicious symptoms and undergo testing for infection?

Detailed description: The aim of this study is to analyse the frequency of positive COVID-19 tests and the infection chains in Solingen since February 2020:

1. a prospective survey (telephone contact) of the positively tested patients is done to analyze the social environment and thus provide information about possible transmission routes. Is transmission mainly within the family through visits from relatives or rather through large extra-familial gatherings, such as in the case of the open huts and après-ski bars in Ischgl? Are there age- or gender-specific transmission routes (personal habits, travel)?
2. analysis of the number of positive tests in connection with general measures to contain the infection (closure of schools, mouthguards obligation, etc.)
3. characterization of positively tested patients based on anthropometric data and medical history.
4. the effect of political events and developments in world affairs on the daily visitor frequency in the COVID-19 outpatient clinic will be retrospectively investigated. Is there an accumulation of tests after speeches by politicians or public figures (Angela Merkel, Armin Laschet, Queen Elizabeth II, etc.) or after dramatic infection numbers in other parts of Germany or Europe (Heinsberg, Ischgl, etc.)?

Eligibility criteria: Inclusion Criteria:

* positive COVID-19 test result

Exclusion Criteria:

* negative COVID-19 test result
* Any medical, psychological or other condition which restricts the ability to provide information or consent of the patient for voluntary participation in this examination

Primary outcomes:
measure: possible risk factors
timeFrame: 0-4 weeks
measure: frequency of positive test results after prescribed protective measures
timeFrame: about 8 months
measure: frequency of positive test results within the family or other social groups
timeFrame: about 8 months
Secondary outcomes:
measure: number of COVID-19 tests in the outpatient clinic
timeFrame: about 8 months
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
state: Nordrhein-Westfalen
Study officials:
References: