COVID-19NCT04521088
Epidemiological Analysis of Ambulant Patients in a COVID-19 Outpatient Clinic
An observational study of COVID-19, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 1,316 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jul 2020to 31 Jul 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: all visitors of the outpatient clinic for COVID-19 since february 2020 in Solingen
Who may be able to join
- positive COVID-19 test result
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, North Rhine-Westphalia, 42699
About this study
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?
Read the 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:
- 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)?
- analysis of the number of positive tests in connection with general measures to contain the infection (closure of schools, mouthguards obligation, etc.)
- characterization of positively tested patients based on anthropometric data and medical history.
- 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.)?
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| visitors of the outpatient clinic for COVID-19 | visitors of the outpatient clinic for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
possible risk factors
medical history and medication of positive tested patients
Measured: 0-4 weeks
frequency of positive test results after prescribed protective measures
frequency of positive test results after prescribed protective measures
Measured: 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
Measured: about 8 months
Secondary outcomes (1)
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
Measured: about 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start2 Jul 2020
- Primary completion30 May 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,316 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Randerath, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521088
- Sponsor's protocol ID
- WI-1252
- Status last verified
- Apr 2022
- First submitted
- 2 Jul 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Analysis of Ambulant Patients in a COVID-19 Outpatient Clinic
- ClinicalTrials.gov ID
- NCT04521088
- Acronym / sponsor ID
- WI-1252
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- analysis of the number of positive tests in connection with general measures to contain the infection (closure of schools, mouthguards obligation, etc.)
- characterization of positively tested patients based on anthropometric data and medical history.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| visitors of the outpatient clinic for COVID-19 | – | –visitors of the outpatient clinic for COVID-19 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all visitors of the outpatient clinic for COVID-19 since february 2020 in Solingen
Key inclusion criteria (1 listed)
- positive COVID-19 test result
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
possible risk factors
Time frame: 0-4 weeks
medical history and medication of positive tested patients
frequency of positive test results after prescribed protective measures
Time frame: about 8 months
frequency of positive test results after prescribed protective measures
frequency of positive test results within the family or other social groups
Time frame: about 8 months
frequency of positive test results within the family or other social groups
1 secondary outcome
number of COVID-19 tests in the outpatient clinic
Time frame: about 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
possible risk factors (time frame: 0-4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.