Epidemiological Multicohort Study of Latent COVID-19 Infections

Epidemiological Multicohort Study of Latent COVID-19 Infections in Residents and Staff of Nursing Homes in the City of Solingen

Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: COVID-19 nasal/pharyngeal swab

Detailed Description

Particular interest is being paid to old people's and nursing homes during the COVID-19 pandemic, as people at particular risk are to be found there. Therefore, the health department of the city of Solingen will carry out extensive testing of both staff and residents for COVID-19 in this sensitive area. The scientific institute Bethanien für Pneumologie e.V. would like to collect and evaluate the data and test results collected in the process in order to record the occurrence of infections in this area and to obtain information on possible routes of infection and the effectiveness of hygiene measures taken. The aims of the study are:

1. Prevalence of latent COVID-19 infections at one point in time among residents and staff of old people's and nursing homes in Solingen.
2. Prevalence of latent COVID-19 infections over a period of 6 months among staff of a single nursing home (=subgroup)
3. Analysis of transmission pathways of the virus in a nursing home
4. Analysis of the effectiveness of hygiene measures taken
5. Analysis of risk factors (previous illnesses, medication, etc.)

• Study Type: Observational
• Enrollment (Actual): 1462

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Solingen, Nordrhein-Westfalen, Germany, 42699
      • Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All residents and staff in the nursing homes in Solingen who consent to participate in the study.

Description

Inclusion Criteria:

• informed consent of the test person or the legally authorised guardian

Exclusion Criteria:

• missing consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
residents and staff of all nursing homes in Solingen; each study participant receives a single nasal/pharyngeal swab	Diagnostic test: COVID-19 nasal/pharyngeal swab; each study participant receives a nasal/pharyngeal swab
staff of one single nursing home in Solingen; each study participant receives a weekly nasal/pharyngeal swab for six months	Diagnostic test: COVID-19 nasal/pharyngeal swab; each study participant receives a nasal/pharyngeal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of latent COVID-19 infections at one point in time among residents and staff of all old people's and nursing homes in Solingen.	number of positive COVID-19 tests	baseline
Prevalence of latent COVID-19 infections over a follow-up period of 6 months among staff of one single nursing home	number of positive COVID-19 tests	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of risk factors (previous illnesses, medication...)	analysis of risk factors for a COVID-19 infection	6 months

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Investigators: Principal Investigator: Winfried Randerath, Krankenhaus Bethanien Solingen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: WI-2020179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No