Epidemiological Multicohort Study of Latent COVID-19 Infections

Sponsor
Wissenschaftliches Institut Bethanien e.V (Other)
Overall Status
Completed
CT.gov ID
NCT04695678
Collaborator
(none)
1,462
1
18
81.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1462 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Epidemiological Multicohort Study of Latent COVID-19 Infections in Residents and Staff of Nursing Homes in the City of Solingen
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. Analysis of risk factors (previous illnesses, medication...) [6 months]

    analysis of risk factors for a COVID-19 infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • informed consent of the test person or the legally authorised guardian
Exclusion Criteria:
  • missing consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V. Solingen Nordrhein-Westfalen Germany 42699

Sponsors and Collaborators

  • Wissenschaftliches Institut Bethanien e.V

Investigators

  • Principal Investigator: Winfried Randerath, Krankenhaus Bethanien Solingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT04695678
Other Study ID Numbers:
  • WI-2020179
First Posted:
Jan 5, 2021
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022