Epidemiological Multicohort Study of Latent COVID-19 Infections

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: COVID-19 nasal/pharyngeal swab

• Registration Number: NCT04695678
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

Brief Summary

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.

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 Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Primary Completion: 2021-07-30
• Study Completion: 2021-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1462

Inclusion Criteria

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

Exclusion Criteria

• missing consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	baseline	number of positive COVID-19 tests
Prevalence of latent COVID-19 infections over a follow-up period of 6 months among staff of one single nursing home	6 months	number of positive COVID-19 tests

Secondary Outcome Measures

Name	Time	Method
Analysis of risk factors (previous illnesses, medication...)	6 months	analysis of risk factors for a COVID-19 infection

Trial Locations

Locations (1)

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