COVID-19 Seroprevalence Study in ITM Staff

Covid19 Clinical Trial

— CovAb  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503447
• Other study ID #: SARSCOV2SEROPREVALENCEITMSTAFF
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: September 9, 2020

Study information

• Verified date: September 2020
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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