CovAb: COVID-19 Seroprevalence Study in ITM Staff

Sponsor

Institute of Tropical Medicine, Belgium (Other)

Overall Status

Completed

CT.gov ID

NCT04503447

Collaborator

(none)

330

Enrollment

Location

1.3

Actual Duration (Months)

257.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

330 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Sep 9, 2020

Actual Study Completion Date :

Sep 9, 2020

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

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