COVID-19 Seroprevalence Study in ITM Staff

NCT04503447 | Completed

• 1 other identifier: SARSCOV2SEROPREVALENCEITMSTAFF
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its second wave. The Belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. To decide which containment measures should be maintained, reinstalled or suspended, information on what proportion of people has been infected and on possible risk factors for virus transmission can be helpful. This study will be conducted on staff members of the ITM. All staff members will be invited to participate. Participants will be asked to have a blood sample drawn for detections of antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2 ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to complete a questionnaire about their exposure, both within and outside the ITM, to the SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.

Conditions

Covid19

Keywords

humans; COVID-19; pandemics; SARS virus; cross-sectional studies; seroepidemiological studies; Belgium; risk factors; seroprevalence

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 seroprevalence ITM staff

  The proportion of participating ITM staff members with detectable SARS-CoV-2 antibodies

  Sample is drawn once, within 7 days after recruitment

Secondary Outcomes (1)

• SARS-CoV-2 seroprevalence in ITM staff, stratified by variables

  Questionnaire is completed once, at recruitment

Other Outcomes (1)

• Risk or protective factors for SARS-CoV-2 seropositivity

  Questionnaire is completed once, at recruitment

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active ITM staff members

You may qualify if:

• Be an active ITM staff member
• Be willing and able to complete the questionnaire
• Be willing and able to provide informed consent

You may not qualify if:

• Doctor of Philosophy (PhD) students, Master students and interns of the ITM

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

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

• Marjan Van Esbroeck, MD

  Institute of Tropical Medicine, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)