Clinical trial NCT04738695: SARS-CoV-2 Seroprevalence Among Nursing Home Staff and Residents (COVID-19)
Official title: SARS-CoV-2 Seroprevalence Among Nursing Home Staff and Residents in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV-2 Infection
Keywords: Covid19
SARS-CoV-2 Infection
Seroprevalence
Nursing home
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: KU Leuven
name: University of Liege
name: Universiteit Antwerpen
First posted: 2021-02-04
Enrollment: 3008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nursing Home residents and staff members.

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change of seroprevalence of anti-SARS-CoV-2 antibodies among nursing home residents and staff in Belgium
timeFrame: "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"
measure: Change in SARS-CoV-2 seroconversion among nursing home residents and staff in Belgium
timeFrame: "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"
Secondary outcomes:
measure: Assess the risk of getting symptomatically SARS-CoV-2 infected between the seropositive and seronegative group at baseline
timeFrame: 10 months
measure: Assess the proportion of deaths within 10 months between sero-positive and -negative participants at baseline visit for NH residents.
timeFrame: 10 months
measure: 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)
timeFrame: 10 months
measure: Assess the duration of SARS-CoV-2 antigen specific seropositivity among NH residents and staff in Belgium.
timeFrame: 10 months
measure: Assess the time until death within 10 months between sero-positive and -negative participants at baseline visit for NH residents
timeFrame: 10 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: An De Sutter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.