Covid19NCT04813497
Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members
A study testing Serology to determine SARS-CoV-2 infection in people with Covid19, run by Grand Hôpital de Charleroi at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Serology to determine SARS-CoV-2 infection
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Feb 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be an employee or independent collaborator at the GHdC
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members: Protocol for an Interventional Cohort Study in 2020-2021
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Serology to determine SARS-CoV-2 infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology to determine SARS-CoV-2 infectionDiagnostic test
Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
| Study group | Role | What they receive |
|---|---|---|
| Participants who refuse the SARS-CoV-2 vaccine | Other | 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. Receives: Diagnostic Test: Serology to determine SARS-CoV-2 infection |
| Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test | Other | 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. Receives: Diagnostic Test: Serology to determine SARS-CoV-2 infection |
| Participants who start with the serological test before SARS-CoV-2 vaccine | Other | 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. Receives: Diagnostic Test: Serology to determine SARS-CoV-2 infection |
| Participants who received the third dose of SARS-CoV-2 vaccine | Other | Participant who performs his serological test when he receives the third dose of vaccine against the SARS-CoV-2 virus to determine his immunity. Receives: Diagnostic Test: Serology to determine SARS-CoV-2 infection |
| Participant who received the third dose of SARS-CoV-2 vaccine and | Other | 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. Receives: Diagnostic Test: Serology to determine SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start5 Feb 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natahie de Visscher, MD, Principal investigator, Grand Hôpital de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813497
- Sponsor's protocol ID
- SARS-COV-2-SERO_FU-2021_GHdC
- Status last verified
- May 2022
- First submitted
- 21 Mar 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members: Protocol for an Interventional Cohort Study in 2020-2021
- ClinicalTrials.gov ID
- NCT04813497
- Acronym / sponsor ID
- SARS-COV-2-SERO_FU-2021_GHdC
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants who refuse the SARS-CoV-2 vaccine | Other | Diagnostic Test: Serology to determine SARS-CoV-2 infectionParticipant 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. |
| Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test | Other | Diagnostic Test: Serology to determine SARS-CoV-2 infectionParticipant 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. |
| Participants who start with the serological test before SARS-CoV-2 vaccine | Other | Diagnostic Test: Serology to determine SARS-CoV-2 infectionParticipant 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. |
| Participants who received the third dose of SARS-CoV-2 vaccine | Other | Diagnostic Test: Serology to determine SARS-CoV-2 infectionParticipant 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 received the third dose of SARS-CoV-2 vaccine and | Other | Diagnostic Test: Serology to determine SARS-CoV-2 infectionParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be an employee or independent collaborator at the GHdC
Key exclusion criteria (3 listed)
- Refusal to take a blood test for anti-SARS-CoV-2 antibodies
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serology to determine SARS-CoV-2 infectionEach participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood | Diagnostic test | Participant who received the third dose of SARS-CoV-2 vaccine and, Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test, Participants who received the third dose of SARS-CoV-2 vaccine, Participants who refuse the SARS-CoV-2 vaccine, Participants who start with the serological test before SARS-CoV-2 vaccine |
Primary outcome
Serological tests to know the level of antibodies against SARS CoV-2
Time frame: up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test
Participants accept to undergo 2 serological tests to determine their immunity to the SARS-CoV-2 virus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natahie de Visscher, MD principal investigator
Grand Hôpital de Charleroi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serology to determine SARS-CoV-2 infection in people with Covid19, run by Grand Hôpital de Charleroi at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological tests to know the level of antibodies against SARS CoV-2 (time frame: up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.