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Completed

NCT Number: NCT04933981

Benefit of Expanded Surveillance of 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.

Completed

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Key information

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. SARS-CoV-2 infection among visitors and health-care workers (HCW) of INH

    Time frame: Oct 15th until Dec 18th, 2020

    proof of SARS-CoV-2 DNA (asymptomatic and symptomatic) on nasopharyngeal swab among visitors and HCW in INH

  2. Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen tests

    Time frame: Oct 15th until Dec 18th, 2020

    Ct values in RT-PCR samples of SARS-CoV-2 PCR

  3. Overall mortality, COVID-19 related mortality, and excess mortality

    Time frame: up to two weeks after study completion

    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.

Sponsors and collaborators

Lead sponsor

University of Cologne

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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