COVID-19NCT04695678
Epidemiological Multicohort Study of Latent COVID-19 Infections
An observational study of COVID-19, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 nasal/pharyngeal swab
- How many people
- 1,462 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 30 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All residents and staff in the nursing homes in Solingen who consent to participate in the study.
Who may be able to join
- informed consent of the test person or the legally authorised guardian
Who cannot join
- missing consent
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
Official title: Epidemiological Multicohort Study of Latent COVID-19 Infections in Residents and Staff of Nursing Homes in the City of Solingen
Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup.
Read the detailed description
Particular interest is being paid to old people's and nursing homes during the COVID-19 pandemic, as people at particular risk are to be found there. Therefore, the health department of the city of Solingen will carry out extensive testing of both staff and residents for COVID-19 in this sensitive area. The scientific institute Bethanien für Pneumologie e.V. would like to collect and evaluate the data and test results collected in the process in order to record the occurrence of infections in this area and to obtain information on possible routes of infection and the effectiveness of hygiene measures taken. The aims of the study are:
- Prevalence of latent COVID-19 infections at one point in time among residents and staff of old people's and nursing homes in Solingen.
- Prevalence of latent COVID-19 infections over a period of 6 months among staff of a single nursing home (=subgroup)
- Analysis of transmission pathways of the virus in a nursing home
- Analysis of the effectiveness of hygiene measures taken
- Analysis of risk factors (previous illnesses, medication, etc.)
- Conditions
- COVID-19
- Being tested
- COVID-19 nasal/pharyngeal swab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 nasal/pharyngeal swabDiagnostic test
each study participant receives a nasal/pharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| residents and staff of all nursing homes in Solingen | each study participant receives a single nasal/pharyngeal swab Receives: Diagnostic Test: COVID-19 nasal/pharyngeal swab | |
| staff of one single nursing home in Solingen | each study participant receives a weekly nasal/pharyngeal swab for six months Receives: Diagnostic Test: COVID-19 nasal/pharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of latent COVID-19 infections at one point in time among residents and staff of all old people's and nursing homes in Solingen.
number of positive COVID-19 tests
Measured: baseline
Prevalence of latent COVID-19 infections over a follow-up period of 6 months among staff of one single nursing home
number of positive COVID-19 tests
Measured: 6 months
Secondary outcomes (1)
Analysis of risk factors (previous illnesses, medication...)
analysis of risk factors for a COVID-19 infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jul 2020
- Primary completion30 Jul 2021
- Study completion30 Dec 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
- 1,462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Randerath, Principal investigator, Krankenhaus Bethanien Solingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695678
- Sponsor's protocol ID
- WI-2020179
- Status last verified
- Apr 2022
- First submitted
- 11 Dec 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 Multicohort Study of Latent COVID-19 Infections in Residents and Staff of Nursing Homes in the City of Solingen
- ClinicalTrials.gov ID
- NCT04695678
- Acronym / sponsor ID
- WI-2020179
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,462 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 5 Jan 2021 (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.
Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup.
Detailed description
Particular interest is being paid to old people's and nursing homes during the COVID-19 pandemic, as people at particular risk are to be found there. Therefore, the health department of the city of Solingen will carry out extensive testing of both staff and residents for COVID-19 in this sensitive area. The scientific institute Bethanien für Pneumologie e.V. would like to collect and evaluate the data and test results collected in the process in order to record the occurrence of infections in this area and to obtain information on possible routes of infection and the effectiveness of hygiene measures taken. The aims of the study are:
- Prevalence of latent COVID-19 infections at one point in time among residents and staff of old people's and nursing homes in Solingen.
- Prevalence of latent COVID-19 infections over a period of 6 months among staff of a single nursing home (=subgroup)
- Analysis of transmission pathways of the virus in a nursing home
- Analysis of the effectiveness of hygiene measures taken
- Analysis of risk factors (previous illnesses, medication, etc.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| residents and staff of all nursing homes in Solingen | – | Diagnostic Test: COVID-19 nasal/pharyngeal swabeach study participant receives a single nasal/pharyngeal swab |
| staff of one single nursing home in Solingen | – | Diagnostic Test: COVID-19 nasal/pharyngeal swabeach study participant receives a weekly nasal/pharyngeal swab for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All residents and staff in the nursing homes in Solingen who consent to participate in the study.
Key inclusion criteria (1 listed)
- informed consent of the test person or the legally authorised guardian
Key exclusion criteria (1 listed)
- missing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 nasal/pharyngeal swabeach study participant receives a nasal/pharyngeal swab | Diagnostic test | residents and staff of all nursing homes in Solingen, staff of one single nursing home in Solingen |
Primary outcome
Prevalence of latent COVID-19 infections at one point in time among residents and staff of all old people's and nursing homes in Solingen.
Time frame: baseline
number of positive COVID-19 tests
Prevalence of latent COVID-19 infections over a follow-up period of 6 months among staff of one single nursing home
Time frame: 6 months
number of positive COVID-19 tests
1 secondary outcome
Analysis of risk factors (previous illnesses, medication...)
Time frame: 6 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
Related trials for COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Winfried Randerath principal investigator
Krankenhaus Bethanien Solingen
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 1 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?
Prevalence of latent COVID-19 infections at one point in time among residents and staff of all old people's and nursing homes in Solingen. (time frame: baseline). The study lists 2 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; AzTrials last refreshed its copy on 7 Nov 2026.