Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| City Council of Cologne, Department of Public Health, NRW, Germany | UNKNOWN |
| City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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):
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal swab for SARS-CoV-2 | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Oct 15th until Dec 18th, 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Oct 15th until Dec 18th, 2020 |
| Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen tests |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oliver A Cornely, MD | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34669164 | Derived | 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. |
Not provided
Not provided
IPD can be made available upon request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Testing for SARS-CoV-2 is performed by nasal and/or pharyngeal swab using conventional swab materials. The oropharynx and/or nasopharynx of the participants will be swabbed in an arc for approx. 5 seconds to ensure the highest possible quality of the swab.
The swabbing is performed by qualified medical personnel using personal protective equipment including gloves, disposable gown, hood, goggles and FFP masks.
Samples are brought to the testing laboratory within 12 hours of collection. Further analysis of the nose/throat swabs is performed by PCR at the Institute of Virology, University of Cologne.
Ct values in RT-PCR samples of SARS-CoV-2 PCR |
| 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. | up to two weeks after study completion |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |