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

NCT04933981 | Completed

• 1 other identifier: 3S fuer Koeln
• Study Type: observational
• Target: 1,587
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Respiratory Infection; SARS-CoV-2 Infection

Keywords

Surveillance; COVID-19 pandemic; nursing homes; visiting restrictions during the COVID-19 pandemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Oct 15th until Dec 18th, 2020

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

  Oct 15th until Dec 18th, 2020

• Overall mortality, COVID-19 related mortality, and excess mortality

  up to two weeks after study completion

Study Arms (2)

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)

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

Interventions

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

interventional nursing home (INH).

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• City Council of Cologne, Department of Public Health, NRW, Germany: collaborator
• City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany: collaborator

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

• 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.

  PMID: 34669164 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oliver A Cornely, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctor

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 22, 2021
• Study Start: October 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: June 30, 2021
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)