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SARS-CoV-2 Seroprevalence Among Nursing Home Staff and Residents (COVID-19)

NCT ID: NCT04738695

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3008 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-31

Brief Summary

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Assessment of the seroprevalence and sero-incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) among Nursing Home (NH) residents and staff in Belgium.

Detailed Description

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In this longitudinal cohort study, 3036, nursing home (NH) residents (1656) and staff (1380), spread over 69 nursing homes throughout Belgium will be repeatedly sampled at a 2-month interval. Seroprevalence and -incidence will be assessed by means of a point-of-care rapid antibody test with additional collection of a Dry Blood Spot sample for quantitative detection of immune markers\*. Sample collection (capillary blood samples) at baseline (day 0, week 0) will start in a staggered way, so all baseline samples among the different nursing homes are collected within the first 21 days after collection of the first sample. Follow-up sample collection will occur with a 2-month interval in week 8, week 16, week 24, week 32 and week 40 after the baseline collection of that specific nursing home. At each timepoint, questionnaires will be taken concerning medical history, clinical outcomes and potential COVID-19 riskfactors. The recruited NHs will be equally spread across the Belgian territory according to geographic and demographic characteristics to guarantee general representativity. Forty-four participants (20 staff, 24 residents) will be randomly included per nursing home. (\* collection of the Dry Blood Spot is part of a sub-study by Ghent University)

Conditions

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Covid19 SARS-CoV-2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nursing home residents/staff members

Follow-up of seroprevalence

Point-of-care rapid anti-SARS-CoV-2 antibody test (Orient Gene Biotech) and Dry Blood Spot collection (Euroimmun)

Intervention Type DIAGNOSTIC_TEST

Bimonthly finger pricks with collection of 1-10 drops of capillary blood for detection of anti-SARS-CoV-2 immune markers

Interventions

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Point-of-care rapid anti-SARS-CoV-2 antibody test (Orient Gene Biotech) and Dry Blood Spot collection (Euroimmun)

Bimonthly finger pricks with collection of 1-10 drops of capillary blood for detection of anti-SARS-CoV-2 immune markers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* residents and staff from Belgian nursing homes

Exclusion Criteria

* service flat residents
* temporary staff, employed for a period of less then 1 year starting from baseline collection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Sciensano

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An De Sutter, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

References

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Lipsitch M, Swerdlow DL, Finelli L. Defining the Epidemiology of Covid-19 - Studies Needed. N Engl J Med. 2020 Mar 26;382(13):1194-1196. doi: 10.1056/NEJMp2002125. Epub 2020 Feb 19. No abstract available.

Reference Type BACKGROUND
PMID: 32074416 (View on PubMed)

Meyers E, De Rop L, Deschepper E, Duysburgh E, De Burghgraeve T, Van Ngoc P, Digregorio M, Coen A, De Clercq N, Wallaert S, Buret L, Coenen S, De Sutter A, Scholtes B, Verbakel JY, Cools P, Heytens S. SARS-CoV-2 seroreversion and all-cause mortality in nursing home residents and staff post-primary course vaccination in Belgium between February and December 2021. Vaccine. 2025 Apr 2;51:126865. doi: 10.1016/j.vaccine.2025.126865. Epub 2025 Feb 20.

Reference Type DERIVED
PMID: 39983537 (View on PubMed)

Meyers E, De Rop L, Deschepper E, Duysburgh E, De Burghgraeve T, Van Ngoc P, Digregorio M, Delogne S, Coen A, De Clercq N, Buret L, Coenen S, De Sutter A, Scholtes B, Verbakel JY, Cools P, Heytens S. Prevalence of SARS-CoV-2 antibodies among Belgian nursing home residents and staff during the primary COVID-19 vaccination campaign. Eur J Gen Pract. 2023 Dec;29(2):2149732. doi: 10.1080/13814788.2022.2149732. Epub 2022 Nov 28.

Reference Type DERIVED
PMID: 36440533 (View on PubMed)

Other Identifiers

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BC-08719

Identifier Type: -

Identifier Source: org_study_id