Sars-CoV2COVEMUZNCT04426292
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak
A study testing Serological testing in people with Sars-CoV2, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Serological testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteBelgium
- Study dates
- 12 May 2020to 25 Dec 2021
- 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
- Any adult employee of the UZ Brussel who provided a signed informed consent to participate in the study.
Who cannot join
- UZ Brussel employees whose contract expires within 6 months of study initiation, with the exception of resident trainees (if training continues in another hospital, resident trainees will be asked to perform the last sampling when leaving the UZ Brussel).
- Staff not active during the inclusion period
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Laurien De Greef, Nurse, 1929849, laurien.degreef@uzbrussel.be
Sabine Allard, MD
About this study
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).
This study is a monocentric interventional prospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.
- To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
- To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.
- Conditions
- Sars-CoV2
- Being tested
- Serological testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological testingDiagnostic test
Antibody testing for Sars-COV-2 antibodies in blood.
| Study group | Role | What they receive |
|---|---|---|
| General arm | Other | All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points Receives: Diagnostic Test: Serological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence
- To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
Measured: Change from baseline to 2 months and 5 months timepoint
seroconversions
- To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.
Measured: Change from baseline to 2 months and 5 months timepoint
Secondary outcomes (6)
Incidence of definite cases
- To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among employees of the UZ Brussel over a period of five months.
Measured: Change from baseline to 2 months and 5 months timepoint
Incidence of probable cases
- To document the incidence of new probable cases of COVID-19 (based on study questionnaire) among employees of the UZ Brussel over a period of five months.
Measured: Change from baseline to 2 months and 5 months timepoint
Antibody kinetics
- To document the SARS-CoV-2 antibody kinetics after confirmed and probable COVID-19. Specifically (1) electrostatic interactions, (2) dispersion forces, (3) hydrogen bonds, and (4) hydrophobic interactions.
Measured: Change from baseline to 2 months and 5 months timepoint
Potential work-related risk factors
- To investigate potential work-related risk factors for SARS-CoV-2 infection among employees of the UZ Brussel.
Measured: Change from baseline to 2 months and 5 months timepoint
Proportion of asymptomatic seroconversions
- To quantify the proportion of asymptomatic seroconversions among employees of the UZ Brussel over a period of five months.
Measured: Change from baseline to 2 months and 5 months timepoint
Concerns for safety for infection with COVID-19
- To document the concerns of HCW and non-HCW about their safety for infection with COVID-19.
Measured: Change from baseline to 2 months and 5 months timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start12 May 2020
- Primary completion23 Dec 2021 (estimated)
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426292
- Sponsor's protocol ID
- COVEMUZ
- Acronym
- COVEMUZ
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2020
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak
- ClinicalTrials.gov ID
- NCT04426292
- Acronym / sponsor ID
- COVEMUZ / COVEMUZ
- Conditions
- Sars-CoV2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 23 Dec 2021 (estimated)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 11 Jun 2020 (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.
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).
This study is a monocentric interventional prospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.
- To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
- To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General arm | Other | Diagnostic Test: Serological testingAll patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult employee of the UZ Brussel who provided a signed informed consent to participate in the study.
Key exclusion criteria (2 listed)
- UZ Brussel employees whose contract expires within 6 months of study initiation, with the exception of resident trainees (if training continues in another hospital, resident trainees will be asked to perform the last sampling when leaving the UZ Brussel).
- Staff not active during the inclusion period
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 testingAntibody testing for Sars-COV-2 antibodies in blood. | Diagnostic test | General arm |
Primary outcome
Seroprevalence
Time frame: Change from baseline to 2 months and 5 months timepoint
- To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
seroconversions
Time frame: Change from baseline to 2 months and 5 months timepoint
- To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.
6 secondary outcomes
Incidence of definite cases
Time frame: Change from baseline to 2 months and 5 months timepoint
Incidence of probable cases
Time frame: Change from baseline to 2 months and 5 months timepoint
Antibody kinetics
Time frame: Change from baseline to 2 months and 5 months timepoint
Potential work-related risk factors
Time frame: Change from baseline to 2 months and 5 months timepoint
Proportion of asymptomatic seroconversions
Time frame: Change from baseline to 2 months and 5 months timepoint
Concerns for safety for infection with COVID-19
Time frame: Change from baseline to 2 months and 5 months timepoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 testing in people with Sars-CoV2, run by Universitair Ziekenhuis Brussel 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 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Allard, MD (1923369, sabine.allard@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence (time frame: Change from baseline to 2 months and 5 months timepoint). The study lists 2 primary outcomes in all. 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 4 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.