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Covid19SCOPENCT04738695

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

An observational study of Covid19 and SARS-CoV-2 Infection, run by Sciensano at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19, SARS-CoV-2 Infection
What is being tested?
Point-of-care rapid anti-SARS-CoV-2 antibody test (Orient Gene Biotech) and Dry Blood Spot collection (Euroimmun)
How many people
3,008 participants
Where
1 siteBelgium
Study dates
1 Feb 2021to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Nursing Home residents and staff members.

Who may be able to join

  • residents and staff from Belgian nursing homes

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

Official title: SARS-CoV-2 Seroprevalence Among Nursing Home Staff and Residents in Belgium

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.

Read the detailed description

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)

Being tested
Point-of-care rapid anti-SARS-CoV-2 antibody test (Orient Gene Biotech) and Dry Blood Spot collection (Euroimmun)
Keywords
Covid19, SARS-CoV-2 Infection, Seroprevalence, Nursing home
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04738695
Study groupRoleWhat they receive
Nursing home residents/staff membersFollow-up of seroprevalence
Receives: Diagnostic Test: Point-of-care rapid anti-SARS-CoV-2 antibody test (Orient Gene Biotech) and Dry Blood Spot collection (Euroimmun)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (5)

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

    For all participants, the hazard of new symptomatic SARS-CoV-2 infections between sero-positive and -negative participants at the baseline visit will be estimated and reported as cumulative survival rates after 10 months of follow-up with 95% Confidence Interval (CI). The analysis will account the clustered nature of participants within NH and will be adjusted for the stratification factors province and type of participant (staff vs resident). If a vaccine would become available during the study period, the admission of a vaccine will be added as a time-varying covariate to the analysis.

    Measured: 10 months

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

    For NH residents, the proportion of deaths within 10 months of follow-up between sero-positive and -negative participants at the baseline visit will be assessed. Province, age, gender, care profile, presence of COVID-specific comorbidities at baseline and timevarying covariate COVID-19 vaccine will be considered for model adjustment.

    Measured: 10 months

  3. 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)

    The sero-conversion time in the group of sero-negative participants at the baseline visit will be modelled separately for residents and staff, on the one hand assessing potential differences between care profiles or residence ward (dementia unit or not) for NH residents, and differences between flu vaccination status and type of job assignment for the staff on the other hand. For both types of participants the model will be adjusted for province, age, gender, presence of COVID-specific comorbidities at baseline and time-varying covariate COVID-19 vaccine.

    Measured: 10 months

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

    The duration of SARS-CoV-2 antigen specific seropositivity among NH residents and staff in Belgium will be modelled by means of interval-censored survival analysis.

    Measured: 10 months

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

    For NH residents, the time until death between sero-positive and -negative participants at the baseline visit will be assessed within 10 months. Province, age, gender, care profile, presence of COVID-specific comorbidities at baseline and timevarying covariate COVID-19 vaccine will be considered for model adjustment.

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,008 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738695
Sponsor's protocol ID
BC-08719
Acronym
SCOPE
Status last verified
Nov 2023
First submitted
25 Jan 2021
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be available on request.

Publications

  • 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.

    PubMed 32074416

  • 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.

    PubMed 39983537

  • 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.

    PubMed 36440533

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and SARS-CoV-2 Infection, run by Sciensano at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of seroprevalence of anti-SARS-CoV-2 antibodies among nursing home residents and staff in Belgium (time frame: "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04738695, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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