COVID-19 Seroprevalence Study in ITM Staff (CovAb)

Severe Acute Respiratory Syndrome Coronavirus (CoV) 2 (SARS-CoV-2) Seroprevalence Study in Institute of Tropical Medicine (ITM) Staff

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.

Study Overview

• Status: Completed
• Conditions: Covid19

Detailed Description

The study is observational and will be conducted on ITM staff members. All members will be invited to participate.

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Institute of Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Active ITM staff members

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 seroprevalence in ITM staff, stratified by variables	SARS-CoV-2 seroprevalence in ITM staff members stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.	Questionnaire is completed once, at recruitment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk or protective factors for SARS-CoV-2 seropositivity	To identify factors that are associated with an elevated or reduced risk of seropositivity in ITM staff and the Belgian working population in general.	Questionnaire is completed once, at recruitment

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Investigators: Principal Investigator: Marjan Van Esbroeck, MD, Institute of Tropical Medicine, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; risk factors; humans; Belgium; seroprevalence; pandemics; SARS virus; cross-sectional studies; seroepidemiological studies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SARSCOV2SEROPREVALENCEITMSTAFF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study population being only ITM staff members, individual participant data (IPD) cannot be shared due to privacy reasons

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No