COVID-19 Respiratory InfectionNCT04933981
Benefit of Expanded Surveillance of Nursing Homes During the COVID-19 Pandemic
An observational study of COVID-19 Respiratory Infection and SARS-CoV-2 Infection, run by University of Cologne at 1 site in Germany.
Trial summary
Residents in nursing homes for the senior citizens (NH) are at high risk for death from COVID-19. We investigated whether repeated non-mandatory RT-PCR SARS-CoV-2 surveillance of NH staff and visitors reduces COVID-19 incidence rates in NH residents and allows to reduce visiting restrictions. Read more about this study
- Who is it for?
- Ages 0 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection, SARS-CoV-2 Infection
- What is being tested?
- Nasopharyngeal swab for SARS-CoV-2
- How many people
- 1,587 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2020to 30 Jun 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 0 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * One-time or frequent visitors in care facilities with standard 2 who want to be tested voluntarily * employees in care facilities with standard 2 who want to be tested voluntarily * Successful declaration of consent via the UHC Corona Web Tool
Who may be able to join
- One-time or frequent visitors in care facilities of the INH group who want to be tested for SARS-CoV-2 voluntarily
- employees (HCW) in care facilities of the INH group who want to be tested voluntarily
- Successful declaration of consent via the UKK Corona web tool
Who cannot join
- Visitors and employees in care facilities of the INH group with signs of SARS-CoV-2 infection
- No participants in the context of the study are in principle:
- one-time and frequent visitors in care facilities of the CNH group
- employees in care facilities of the CNH group
- Residents in care facilities of the CNH and the INH group
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: Mobile PCR-based Surveillance for SARS-CoV-2 to Reduce Visiting Restrictions in Nursing Homes During the COVID-19 Pandemic
Residents in nursing homes for the senior citizens (NH) are at high risk for death from COVID-19. We investigated whether repeated non-mandatory RT-PCR SARS-CoV-2 surveillance of NH staff and visitors reduces COVID-19 incidence rates in NH residents and allows to reduce visiting restrictions.
Read the detailed description
Nursing homes for senior citizens are considered risk areas for the transmission of SARS-CoV-2. To protect these risk groups, different strategies have been implemented within the framework of legally applicable conditions. The aim of this study is to observe two procedural standards (e.g. visiting restrictions, hygiene measurements):
- On the one hand, a standard procedure without testing of visitors and employees and
- on the other hand, a standard procedure with additional surveillance by voluntary testing of visitors and staff for SARS-CoV-2 and associated relaxation of measures for contact of visitors with residents.
Both standard procedures are designed to ensure adequate protection against infection. The standard procedure with the use of relaxing the measures after testing aims to make the experience of social isolation more bearable for the residents of care facilities and thus less stressful from a psychological point of view. The extent of such possible effects is not the subject of the present study.
The primary aim of the study is to observe the number of SARS-CoV-2 infections among residents of nursing homes for senior citizens under different procedural standards for infection control.
In this study, various measures specified by care institutions for visits to senior citizens' homes are accompanied by scientific screening. The aim of the screening and the analysis of infection protection measures is to enable this vulnerable group to regain participation in society but still slow down the spread of the virus and prevent an outbreak.
The (mobile) infection control center ("Coronamobil") of the University Hospital of Cologne (UKK) makes a decisive contribution to the longitudinal investigation of a risk population and to the early detection of chains of infection in addition to the surveillance carried out by the authorities. In this study, the Coronamobil and personnel are provided to avoid an additional screening burden for the homes.
Surveillance of nursing homes allows protection of particularly vulnerable populations in the SARS-CoV-2 pandemic, and additional controlled contact. An evidence-based, safe and human visit concept could be transferred from Cologne to the whole of Germany. The resulting scientific knowledge would additionally provide a foundation for the control of future outbreak situations.
- Being tested
- Nasopharyngeal swab for SARS-CoV-2
- Keywords
- Surveillance, COVID-19 pandemic, nursing homes, visiting restrictions during the COVID-19 pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swab for SARS-CoV-2Diagnostic test
in the interventional group, regular, i.e. twice to three times weekly, SARS-CoV-2 testing was offered to health-care workers and visitors of nursing homes
| Study group | Role | What they receive |
|---|---|---|
| interventional nursing home (INH). | regular, twice to three times weekly, and voluntary, i.e. non-mandatory, on-site testing for SARS-CoV-2 of HCW and visitors (INH) Receives: Diagnostic Test: Nasopharyngeal swab for SARS-CoV-2 | |
| control nursing home (CNH) | routine setting without frequent regular testing for SARS-CoV-2 (control nursing homes; CNH). Testing only performed by local health authorities upon medical indication, i.e. non-surveillance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection among residents
SARS-CoV-2 infection among residents in INH and CNH (proof of SARS-CoV-2 DNA on nasopharyngeal swab with or without symptoms of SARS-CoV-2 infection)
Measured: Oct 15th until Dec 18th, 2020
Secondary outcomes (3)
SARS-CoV-2 infection among visitors and health-care workers (HCW) of INH
proof of SARS-CoV-2 DNA (asymptomatic and symptomatic) on nasopharyngeal swab among visitors and HCW in INH
Measured: Oct 15th until Dec 18th, 2020
Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen tests
Ct values in RT-PCR samples of SARS-CoV-2 PCR
Measured: Oct 15th until Dec 18th, 2020
Overall mortality, COVID-19 related mortality, and excess mortality
Overall mortality, COVID-19 related mortality defined as death while infected with SARS-CoV-2, and excess mortality were assessed by comparing NH mortality data of the same period in the previous year.
Measured: up to two weeks after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start15 Oct 2020
- Primary completion15 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Respiratory InfectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,587 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- City Council of Cologne, Department of Public Health, NRW, Germany, City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany
- Responsible party
- Principal investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A Cornely, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933981
- Sponsor's protocol ID
- 3S fuer Koeln
- Status last verified
- Apr 2024
- First submitted
- 21 May 2021
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be made available upon request
Publications
Stemler J, Kramer T, Dimitriou V, Wieland U, Schumacher S, Sprute R, Oberste M, Wiesmuller G, Rau H, Pieper S, Bethe U, Lehmann C, Hellmich M, Klein F, Langebartels G, Cornely OA. Mobile PCR-based surveillance for SARS-CoV-2 to reduce visiting restrictions in nursing homes during the COVID-19 pandemic: a pilot study. Infection. 2022 Jun;50(3):607-616. doi: 10.1007/s15010-021-01716-4. Epub 2021 Oct 20.
PubMed 34669164
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile PCR-based Surveillance for SARS-CoV-2 to Reduce Visiting Restrictions in Nursing Homes During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04933981
- Acronym / sponsor ID
- 3S fuer Koeln
- Keywords
- Surveillance, COVID-19 pandemic, nursing homes, visiting restrictions during the COVID-19 pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,587 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- City Council of Cologne, Department of Public Health, NRW, Germany, City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Jun 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.
Residents in nursing homes for the senior citizens (NH) are at high risk for death from COVID-19. We investigated whether repeated non-mandatory RT-PCR SARS-CoV-2 surveillance of NH staff and visitors reduces COVID-19 incidence rates in NH residents and allows to reduce visiting restrictions.
Detailed description
Nursing homes for senior citizens are considered risk areas for the transmission of SARS-CoV-2. To protect these risk groups, different strategies have been implemented within the framework of legally applicable conditions. The aim of this study is to observe two procedural standards (e.g. visiting restrictions, hygiene measurements):
- On the one hand, a standard procedure without testing of visitors and employees and
- on the other hand, a standard procedure with additional surveillance by voluntary testing of visitors and staff for SARS-CoV-2 and associated relaxation of measures for contact of visitors with residents.
Both standard procedures are designed to ensure adequate protection against infection. The standard procedure with the use of relaxing the measures after testing aims to make the experience of social isolation more bearable for the residents of care facilities and thus less stressful from a psychological point of view. The extent of such possible effects is not the subject of the present study.
The primary aim of the study is to observe the number of SARS-CoV-2 infections among residents of nursing homes for senior citizens under different procedural standards for infection control.
In this study, various measures specified by care institutions for visits to senior citizens' homes are accompanied by scientific screening. The aim of the screening and the analysis of infection protection measures is to enable this vulnerable group to regain participation in society but still slow down the spread of the virus and prevent an outbreak.
The (mobile) infection control center ("Coronamobil") of the University Hospital of Cologne (UKK) makes a decisive contribution to the longitudinal investigation of a risk population and to the early detection of chains of infection in addition to the surveillance carried out by the authorities. In this study, the Coronamobil and personnel are provided to avoid an additional screening burden for the homes.
Surveillance of nursing homes allows protection of particularly vulnerable populations in the SARS-CoV-2 pandemic, and additional controlled contact. An evidence-based, safe and human visit concept could be transferred from Cologne to the whole of Germany. The resulting scientific knowledge would additionally provide a foundation for the control of future outbreak situations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional nursing home (INH). | – | Diagnostic Test: Nasopharyngeal swab for SARS-CoV-2regular, twice to three times weekly, and voluntary, i.e. non-mandatory, on-site testing for SARS-CoV-2 of HCW and visitors (INH) |
| control nursing home (CNH) | – | –routine setting without frequent regular testing for SARS-CoV-2 (control nursing homes; CNH). Testing only performed by local health authorities upon medical indication, i.e. non-surveillance testing |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * One-time or frequent visitors in care facilities with standard 2 who want to be tested voluntarily * employees in care facilities with standard 2 who want to be tested voluntarily * Successful declaration of consent via the UHC Corona Web Tool
Key inclusion criteria (3 listed)
- One-time or frequent visitors in care facilities of the INH group who want to be tested for SARS-CoV-2 voluntarily
- employees (HCW) in care facilities of the INH group who want to be tested voluntarily
- Successful declaration of consent via the UKK Corona web tool
Key exclusion criteria (5 listed)
- Visitors and employees in care facilities of the INH group with signs of SARS-CoV-2 infection
- No participants in the context of the study are in principle:
- one-time and frequent visitors in care facilities of the CNH group
- employees in care facilities of the CNH group
- Residents in care facilities of the CNH and the INH group
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 |
|---|---|---|
| Nasopharyngeal swab for SARS-CoV-2in the interventional group, regular, i.e. twice to three times weekly, SARS-CoV-2 testing was offered to health-care workers and visitors of nursing homes | Diagnostic test | interventional nursing home (INH). |
Primary outcome
SARS-CoV-2 infection among residents
Time frame: Oct 15th until Dec 18th, 2020
SARS-CoV-2 infection among residents in INH and CNH (proof of SARS-CoV-2 DNA on nasopharyngeal swab with or without symptoms of SARS-CoV-2 infection)
3 secondary outcomes
SARS-CoV-2 infection among visitors and health-care workers (HCW) of INH
Time frame: Oct 15th until Dec 18th, 2020
Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen tests
Time frame: Oct 15th until Dec 18th, 2020
Overall mortality, COVID-19 related mortality, and excess mortality
Time frame: up to two weeks after study completion
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 8 Apr 2024.
- Derived from this study: PubMed 34669164Stemler J, Kramer T, Dimitriou V, Wieland U, Schumacher S, Sprute R, Oberste M, Wiesmuller G, Rau H, Pieper S, Bethe U, Lehmann C, Hellmich M, Klein F, Langebartels G, Cornely OA. Mobile PCR-based surveillance for SARS-CoV-2 to reduce visiting restrictions in nursing homes during the COVID-19 pandemic: a pilot study. Infection. 2022 Jun;50(3):607-616. doi: 10.1007/s15010-021-01716-4. Epub 2021 Oct 20.
- Individual participant dataSharing planned: No. IPD can be made available upon request
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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.
Oliver A Cornely, MD principal investigator
University of Cologne
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 Respiratory Infection and SARS-CoV-2 Infection, run by University of Cologne 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 3 inclusion and 5 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 8 Apr 2024. 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?
SARS-CoV-2 infection among residents (time frame: Oct 15th until Dec 18th, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04933981, which also lists 1 linked publication.
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 8 Apr 2024.