Clinical trial NCT04813497: Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members
Official title: Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members: Protocol for an Interventional Cohort Study in 2020-2021
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Grand Hôpital de Charleroi
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 : participants who did not agree to receive a SARS-CoV-2 vaccine in the first Belgian campaing but who agreed to perform a serological test against COVID-19.

Groups of participants who agree to receive a SARS-CoV-2 vaccine at different specific times determined by the Belgian State for workers at the Grand Hôpital de Charleroi.

Parallel study of immunity to SARS-CoV-2 among staff members.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serological tests to know the level of antibodies against SARS CoV-2
timeFrame: up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
Study officials:
affiliation: Grand Hôpital de Charleroi
name: Natahie de Visscher, MD
role: PRINCIPAL_INVESTIGATOR
References: