Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

Covid19 Clinical Trial

Official title:

Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members: Protocol for an Interventional Cohort Study in 2020-2021

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813497
• Other study ID #: SARS-COV-2-SERO_FU-2021_GHdC
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Grand Hôpital de Charleroi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Grand Hôpital de Charleroi (GHdC) had to organize the vaccination of its staff in December 2021 against SARS-CoV-2.On the sidelines of this vaccination campaign, the management committee agreed to document the knowledge of the SARS-CoV-2 serology of all the staff of the establishment before this vaccination campaign, as well as a few weeks after vaccination.

In November 2021, the Belgian government decided to offer a third dose of vaccine against SARS-CoV-2 virus. The GHdC managment committee has agreed to continue monitoring SARS-CoV-2 serology for members who receive their third dose of vaccine.

Description:

Grand Hôpital de Charleroi (GHdC) staff were exposed to the risk of SARS-CoV-2 infection during the first half of 2020: a seroprevalence survey, conducted in the summer of 2020, after the "first wave" of the epidemic, and before the "second wave", thus revealed a significant seroprevalence because of its exposure. This study, because of its high participation rate, also showed the sustained interest of the agents in knowing their serology, either for personal reasons, or for the purposes of recognition as an occupational disease.

The GHdC decided in December 2020 to organize as soon as possible the vaccination of its salaried and self-employed employees who wish to take advantage of this opportunity. On the sidelines of this vaccination campaign, the management committee agreed to document the knowledge of the SARS-Cov-2 serology of all the staff of the establishment before this vaccination campaign, as well as a few weeks after vaccination. This knowledge must better organize the disease prevention strategy, both with regard to the staff themselves and the patients for whom they are called upon to treat.

When the Belgian government decided in November 2021 to offer a third dose of vaccine and start it up in hospitals, the GHdC managment committee has agreed to continue monitoring SARS-CoV-2 serology for members who agree to receive their third dose of vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be an employee or independent collaborator at the GHdC

Exclusion Criteria:

• Refusal to take a blood test for anti-SARS-CoV-2 antibodies

Regarding amendment 1:

• Members who did not receive the third dose of PFIZER vaccine (Comirnaty) during the GHdC vaccination campaign and who did not performed a blood test to measure anti-SARS-CoV-2 antibodies.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Serology to determine SARS-CoV-2 infection
Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood

Locations

Country	Name	City	State
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Grand Hôpital de Charleroi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serological tests to know the level of antibodies against SARS CoV-2	Participants accept to undergo 2 serological tests to determine their immunity to the SARS-CoV-2 virus.	up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test