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Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Serology to determine SARS-CoV-2 infection
Sponsored by
Grand Hôpital de Charleroi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Grand Hôpital de Charleroi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Participants who refuse the SARS-CoV-2 vaccine

Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test

Participants who start with the serological test before SARS-CoV-2 vaccine

Participants who received the third dose of SARS-CoV-2 vaccine

Participant who received the third dose of SARS-CoV-2 vaccine and

Arm Description

Participant who does not wish to be vaccinated against the SARS-CoV-2 virus and who wishes to perform the serological test during the vaccination campaign and the second 12-14 weeks after the first serological test.

Participant who has received his first dose of vaccine and who performs his serological test when he receives the second dose of vaccine against the SARS-CoV-2 virus to determine his immunity. The second serological test will be done 12 to 14 weeks after the second dose of the SARS-CoV-2 vaccine to determine its immunity.

Participant who performed the serological test before the first dose of vaccine and 12 to 14 weeks after the second dose of vaccine against the SARS-CoV-2 virus to determine his immunity.

Participant who performs his serological test when he receives the third dose of vaccine against the SARS-CoV-2 virus to determine his immunity.

Participant who performs a serological test between 12 and 14 weeks after the third dose of SARS-CoV-2 vaccine to determine immunity. And who has agreed to undergo serological testing prior to the third dose of the vaccine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2021
Last Updated
May 31, 2022
Sponsor
Grand Hôpital de Charleroi
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1. Study Identification

Unique Protocol Identification Number
NCT04813497
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grand Hôpital de Charleroi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants who refuse the SARS-CoV-2 vaccine
Arm Type
Other
Arm Description
Participant who does not wish to be vaccinated against the SARS-CoV-2 virus and who wishes to perform the serological test during the vaccination campaign and the second 12-14 weeks after the first serological test.
Arm Title
Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test
Arm Type
Other
Arm Description
Participant who has received his first dose of vaccine and who performs his serological test when he receives the second dose of vaccine against the SARS-CoV-2 virus to determine his immunity. The second serological test will be done 12 to 14 weeks after the second dose of the SARS-CoV-2 vaccine to determine its immunity.
Arm Title
Participants who start with the serological test before SARS-CoV-2 vaccine
Arm Type
Other
Arm Description
Participant who performed the serological test before the first dose of vaccine and 12 to 14 weeks after the second dose of vaccine against the SARS-CoV-2 virus to determine his immunity.
Arm Title
Participants who received the third dose of SARS-CoV-2 vaccine
Arm Type
Other
Arm Description
Participant who performs his serological test when he receives the third dose of vaccine against the SARS-CoV-2 virus to determine his immunity.
Arm Title
Participant who received the third dose of SARS-CoV-2 vaccine and
Arm Type
Other
Arm Description
Participant who performs a serological test between 12 and 14 weeks after the third dose of SARS-CoV-2 vaccine to determine immunity. And who has agreed to undergo serological testing prior to the third dose of the vaccine.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serology to determine SARS-CoV-2 infection
Intervention Description
Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
Primary Outcome Measure Information:
Title
Serological tests to know the level of antibodies against SARS CoV-2
Description
Participants accept to undergo 2 serological tests to determine their immunity to the SARS-CoV-2 virus.
Time Frame
up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natahie de Visscher, MD
Organizational Affiliation
Grand Hôpital de Charleroi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6060
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

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