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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933981
• Other study ID #: 3S fuer Koeln
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2024
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1587
• Est. completion date: June 30, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Respiratory Tract Infections
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• Nasopharyngeal swab for SARS-CoV-2
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

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	NRW

Sponsors (3)

Lead Sponsor	Collaborator
University of Cologne	City Council of Cologne, Department of Public Health, NRW, Germany, City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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