Benefit of Expanded Surveillance of Nursing Homes During the COVID-19 Pandemic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile PCR-based Surveillance for SARS-CoV-2 to Reduce Visiting Restrictions in Nursing Homes During the COVID-19 Pandemic

Conditions
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COVID-19 Respiratory Infection, SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal swab for SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| interventional nursing home (INH).<br>regular, twice to three times weekly, and voluntary, i.e. non-mandatory, on-site testing for SARS-CoV-2 of HCW and visitors (INH) | Diagnostic Test: Nasopharyngeal swab for SARS-CoV-2<br>* 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<br>|
| control nursing home (CNH)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surveillance, COVID-19 pandemic, nursing homes, visiting restrictions during the COVID-19 pandemic