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

NCT04738695 | Completed

• 1 other identifier: BC-08719
• Study Type: observational
• Target: 3,008
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; SARS-CoV-2 Infection

Keywords

Covid19; SARS-CoV-2 Infection; Seroprevalence; Nursing home

Outcome Measures

Primary Outcomes (2)

• Change of seroprevalence of anti-SARS-CoV-2 antibodies among nursing home residents and staff in Belgium

  Change of seroprevalence of anti-SARS-CoV-2 antibodies among Belgian nursing home residents and staff detected in their capillary blood by a point of care test during a period of 10 months.

  "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"

• Change in SARS-CoV-2 seroconversion among nursing home residents and staff in Belgium

  Change in SARS-CoV-2 seroconversion among Belgian nursing home residents and staff conducted by detecting specific SARS-CoV-2 IgG/IgM in their capillary blood by a point of care test at each of the study follow-up testing points.

  "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"

Secondary Outcomes (5)

• Assess the risk of getting symptomatically SARS-CoV-2 infected between the seropositive and seronegative group at baseline

  10 months

• Assess the proportion of deaths within 10 months between sero-positive and -negative participants at baseline visit for NH residents.

  10 months

• Assess the seroconversion time in the group of sero-negative participants at baseline visit in relation to observed risk factors such as care dependency scale (for NH residents),type of job assignment and flu vaccination (for staff)

  10 months

• Assess the duration of SARS-CoV-2 antigen specific seropositivity among NH residents and staff in Belgium.

  10 months

• Assess the time until death within 10 months between sero-positive and -negative participants at baseline visit for NH residents

  10 months

Study Arms (1)

Nursing home residents/staff members

Follow-up of seroprevalence

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

Interventions

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

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

Nursing home residents/staff members

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Nursing Home residents and staff members.

You may qualify if:

• residents and staff from Belgian nursing homes

You may not qualify if:

• service flat residents
• temporary staff, employed for a period of less then 1 year starting from baseline collection

Sponsors & Collaborators

• Sciensano: lead
• KU Leuven: collaborator
• University of Liege: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 32074416 BACKGROUND

• 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.

  PMID: 39983537 DERIVED

• 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.

  PMID: 36440533 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Capillary blood (whole blood) samples: * collection using point-of-care rapid SARS-CoV-2 antibody test * collection on Dry Blood Spot saver card

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• An De Sutter, Prof. Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 4, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At the earliest 3 months after database lock, available for 10 years.
• Access Criteria: Available on request through e-mail correspondence to principal investigator.

Locations

BE (1)