Epidemiological Analysis of Ambulant Patients in a COVID-19 Outpatient Clinic

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?

Study Overview

• Status: Completed
• Conditions: COVID-19

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.)?

• Study Type: Observational
• Enrollment (Actual): 1316

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Solingen, Nordrhein-Westfalen, Germany, 42699
      • Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all visitors of the outpatient clinic for COVID-19 since february 2020 in Solingen

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
visitors of the outpatient clinic for COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
possible risk factors	medical history and medication of positive tested patients	0-4 weeks
frequency of positive test results after prescribed protective measures	frequency of positive test results after prescribed protective measures	about 8 months
frequency of positive test results within the family or other social groups	frequency of positive test results within the family or other social groups	about 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of COVID-19 tests in the outpatient clinic	number of COVID-19 tests in the outpatient clinic against the background of events in world affairs	about 8 months

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2020
• Primary Completion (ACTUAL): May 30, 2021
• Study Completion (ACTUAL): July 31, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: WI-1252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No