COVID-19 Seroprevalence Study in ITM Staff

Completed

• Conditions: Covid19

• Registration Number: NCT04503447
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Detailed Description

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

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Status Verified: 2020-09
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 seroprevalence ITM staff	Sample is drawn once, within 7 days after recruitment	The proportion of participating ITM staff members with detectable SARS-CoV-2 antibodies

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 seroprevalence in ITM staff, stratified by variables	Questionnaire is completed once, at recruitment	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.

Trial Locations

Locations (1)

Institute of Tropical Medicine; 🇧🇪 Antwerp, Belgium