NCT04695678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

December 11, 2020

Last Update Submit

April 26, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Analysis of risk factors (previous illnesses, medication...)

    6 months

Study Arms (2)

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

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

Interventions

COVID-19 nasal/pharyngeal swabDIAGNOSTIC_TEST

each study participant receives a nasal/pharyngeal swab

residents and staff of all nursing homes in Solingenstaff of one single nursing home in Solingen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • missing consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Winfried Randerath

    Krankenhaus Bethanien Solingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

January 5, 2021

Study Start

July 1, 2020

Primary Completion

July 30, 2021

Study Completion

December 30, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)