Covid19NCT04723290
COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020
A study testing Serological tests for SARS Cov-2 in people with Covid19, run by Grand Hôpital de Charleroi at 1 site in Belgium.
Trial summary
The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms. 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?
- Serological tests for SARS Cov-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,817 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2020to 31 Dec 2020
- 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
- Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic.
Who cannot join
- Not be part of the staff of the Grand Hôpital de Charleroi.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 Seroconversion Study Among GHdC Staff Members
The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms.
Read the detailed description
At the start of the SARS-CoV-2 pandemic, several workers had symptoms compatible with COVID-19 at a time when PCR (smear) testing was only allowed for hospitalized people. In addition, the PCR test has a fairly low sensitivity. In this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to SARS-CoV-2.
As a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment.
.
- Conditions
- Covid19
- Being tested
- Serological tests for SARS Cov-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological tests for SARS Cov-2Diagnostic test
Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood
| Study group | Role | What they receive |
|---|---|---|
| Serological tests | Experimental | All staff at GHdC who want to know their level of antibodies against SARS CoV-2 Receives: Diagnostic Test: Serological tests for SARS Cov-2 |
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
The hospital has organized several schedules and appointments for each staff member depending on the ability to analyze laboratory samples and blood draws.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start20 Jun 2020
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie de Visscher, MD, Principal investigator, Grand Hôpital de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723290
- Sponsor's protocol ID
- SERO-SARS-CoV-2 GHdC
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this moment, there is no plan to share the results
Publications
de Visscher N, Holemans X, Gillain A, Kornreich A, Lagasse R, Piette P, Ventura M, Thys F. SARS-CoV-2 Seroprevalence among Healthcare Workers after the First and Second Pandemic Waves. Viruses. 2022 Jul 14;14(7):1535. doi: 10.3390/v14071535.
PubMed 35891515
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Seroconversion Study Among GHdC Staff Members
- ClinicalTrials.gov ID
- NCT04723290
- Acronym / sponsor ID
- SERO-SARS-CoV-2 GHdC
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,817 participants (actual)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Jan 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.
The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms.
Detailed description
At the start of the SARS-CoV-2 pandemic, several workers had symptoms compatible with COVID-19 at a time when PCR (smear) testing was only allowed for hospitalized people. In addition, the PCR test has a fairly low sensitivity. In this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to SARS-CoV-2.
As a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment.
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serological tests | Experimental | Diagnostic Test: Serological tests for SARS Cov-2All staff at GHdC who want to know their level of antibodies against SARS CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic.
Key exclusion criteria (1 listed)
- Not be part of the staff of the Grand Hôpital de Charleroi.
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 |
|---|---|---|
| Serological tests for SARS Cov-2Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood | Diagnostic test | Serological tests |
Primary outcome
Serological tests to know the level of antibodies against SARS CoV-2
Time frame: up to 6 weeks
The hospital has organized several schedules and appointments for each staff member depending on the ability to analyze laboratory samples and blood draws.
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 25 Mar 2021.
- Derived from this study: PubMed 35891515de Visscher N, Holemans X, Gillain A, Kornreich A, Lagasse R, Piette P, Ventura M, Thys F. SARS-CoV-2 Seroprevalence among Healthcare Workers after the First and Second Pandemic Waves. Viruses. 2022 Jul 14;14(7):1535. doi: 10.3390/v14071535.
- Individual participant dataSharing planned: No. At this moment, there is no plan to share the results
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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.
Nathalie 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 Serological tests for SARS Cov-2 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 1 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 25 Mar 2021. 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 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723290, which also lists 1 linked publication.
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 25 Mar 2021.