SARS-CoV-2COVHECBEHONCT04373889
COVID-19 Among Healthcare Workers in Belgian Hospitals
An observational study of SARS-CoV-2 and COVID-19, run by Sciensano at 1 site in Belgium.
Trial summary
Due to the situation this study, originally planted until September 2020, was extended with 7 months until April 2021. This extension was approved by the ethical committee University hospital Ghent, Belgium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- How many people
- 850 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Apr 2020to 30 Apr 2021
- Phase
- Observational
- 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
Study population: Study population include health care workers currently working in Belgian hospitals. According to current national guidelines, HCW in contact with persons at risk for COVID-19 experiencing mild respiratory symptoms without fever are allowed to work if clinical condition permits, while wearing a mask and observing usual hygiene measures. Healthcare workers experiencing respiratory symptoms and fever are systematically tested and if positive, isolated at home, if negative, eventually working wearing a mask if the clinical state allows it. Those who recovered from a documented infection are also allowed to work. HCW who are not in contact with persons at risk for COVID-19 are not tested and systematically isolated in case of any unusual respiratory symptom. This implies that at baseline, the study population will only include asymptomatic or paucisymptomatic HCW applying proper infection prevention measures.
Who may be able to join
- Any permanent medical and paramedical staff working in the hospital who provided a signed informed consent to participate in the study.
- Participants must have a social security insurance (mandatory in Belgium).
- This study only include adults.
Who cannot join
- Staff hired on a temporary (interim) basis will be excluded as follow-up over time will be compromised.
- Administrative staff or technical staff will also be excluded.
- HCW who were not active during the inclusion period will automatically be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-COV-2 Prevalence, Seroprevalence and Seroconversion Among Healthcare Workers in Belgium During the 2020 COVID-19 Outbreak
Due to the situation this study, originally planted until September 2020, was extended with 7 months until April 2021. This extension was approved by the ethical committee University hospital Ghent, Belgium.
The novel SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated Coronavirus type 2) is rapidly spreading over the world causing a condition called Coronavirus disease 2019 (COVID-19). Hospital health care workers (HCW) have received detailed instructions to protect themselves against this infection, but it is likely that at least some of the HCW will get infected either at their workplace or elsewhere. It would be useful to document prevalence and seroprevalence of SARS-CoV-2 and their monthly evolution among Belgian active hospital HCW during a period of 12 months starting beginning of April 2020 and the number of new cases (incidence) of COVID-19 and SARS-CoV-2 seroconversions among Belgian hospital HCW during a period of 12 months which are the primary objectives of this study.
Read more
Additionally the study will validate serological tests (subject to change/addition depending on the evolution of scientific research) against the plaque reduction neutralization test (PRNT) (gold standard); validate the saliva sample (sampling with Oracol or equivalent) against the standard naso/oro pharyngeal swabbing (NOPS) to perform RT-qPCR for SARS-CoV-2 diagnostic purposes, as well as against the standard serology (serum); validate the nasal swab against the standard (NOPS) to perform RT-qPCR for SARS-CoV-2 for diagnostic purposes; investigate potential risk factors for the infection; quantify the proportion of asymptomatic cases among new cases that develop during a period of 12 months.
To reach these primary and secondary objectives the researchers will conduct a prospective cohort study in which a random selection of HCW currently working in Belgian hospitals will be tested monthly (with for the first month an additional testing point at 14 days). The testing will include four kind of laboratory tests, being; a molecular (PCR) test on a nasopharyngeal, a saliva and nasal sample (for nasal and saliva sample only testing until 50 PCR positive and 50 PCR negative samples are collected) and a serological test for which a blood sample is needed. To asses risk factors, at each testing point a questionnaire providing basic socio-demographic and health characteristics of the HCW including presence of symptoms since the previous testing point and the HCW's involvement in caring for COVID-19 patients will be completed.
Laboratory data and epidemiological data (questionnaire) will be collected simultaneously. In each of the participating hospitals, one contact person will be designated to coordinate the study locally (ideally a staff member of the local infection and prevention control team) and communicate with the researchers. The sample size calculation indicated the inclusion of 17 randomly selected Belgian hospitals and in each hospital 50 randomly selected HCW. HCW can only be enrolled in the study after give a written informed consent.
Laboratory testing will be performed at the Virology Diseases and Immune Response services of Sciensano, Ukkel, and the Virology Laboratory of the Institute of Tropical Medicine, Antwerp. The laboratory test results will be communicated by the laboratory to each participant. Each participant and sample will have a unique code assigned. Data collected through the questionnaire will be send psuedonymised (using the unique code) to the epidemiologist at Sciensano. The laboratory will prepare a list of test results by unique code to be linked for further analysis with the questionnaire data. None of the researchers who will analyse the data will be involved in data collection, nor in the care of COVID-19 patients.
This study is a Belgian multicentric study executed by Sciensano, Brussels, in collaboration with the Institute of Tropical Medicine, Antwerp.
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- SARS-CoV-2, COVID-19, Hospital healthcare workers, Belgium, Pandemic 2020, Hospital
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW)
Change in the percentage of HCW with positive RT-qPCR test on nasopharyngeal swabs among all HCW tested
Measured: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW)
Change in the absolute number of HCW with positive RT-qPCR test on nasopharyngeal swabs among the total number of all HCW tested
Measured: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change of seroprevalence of SARS-CoV-2 among Belgian active hospital HCW
Change in percentage of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among all HCW tested
Measured: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change of seroprevalence of SARS-CoV-2 among Belgian active hospital HCW
Change in the absolute number of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among the total number of all HCW tested
Measured: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in new cases (incidence) of COVID-19 among Belgian hospital HCW
Change in the percentage of HCW with positive RT-qPCR test on nasopharyngeal swabs among all HCW tested detected at each of the study follow-up testing points that did not have a positive RT-qPCR test before.
Measured: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in new cases (incidence) of COVID-19 among Belgian hospital HCW
Change in absolute number of HCW with positive RT-qPCR test on nasopharyngeal swabs among the total number of HCW tested detected at each of the study follow-up testing points that did not have a positive RT-qPCR test before.
Measured: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in SARS-CoV-2 seroconversion among Belgian hospital HCW
Change in the percentage of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among all HCW tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Measured: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in SARS-CoV-2 seroconversion among Belgian hospital HCW
Change in the absolute number of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among the total number of HCW tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Measured: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Secondary outcomes (6)
Sensitivity and specificity of serological tests
For serological analyses, the "background" serological positivity of the HCW to various CoV will be tested in order to have a clear view on true seroconversions. Antibody titers (IgM/IgG) against SARS-CoV-2; HKU-1 and OC-43 as well as 229-E and NL-63 will be determined in order to assess specificity and document potential seroconversion. Furthermore, the presently available serological tests need to be validated and confirmed with a plaque reduction neutralization test (PRNT). To that end researchers will use a Vero cell-based in vitro virus neutralization test.
Measured: "Month 3"
Sensitivity and specificity of saliva sampling method (sampling with Oracol or equivalent)
RT-qPCR will be done on the matching saliva sample, enabling to validate or not saliva sampling for SARS-CoV-2 detection (calculating test sensitivity and specificity). serology will equally be performed on saliva samples enabling to validate or not the saliva sampling for antibody (IgM/IgG) detection (calculate test sensitivity and specificity).
Measured: "Month 3"
Validate the nasal swab against the standard
RT-qPCR will be done on the matching nasal swab, enabling to validate or not nasal swab for SARS-CoV-2 detection (calculating test sensitivity and specificity)
Measured: "Month 3"
Potential risk factors for the infection
Proportion (%) infected HCW by professional exposure (specific function, specialty of ward, contact with confirmed case), and by health characteristics (co-morbidities, presence of symptoms, use of medications).
Measured: "Month 5" and "Month 12"
The proportion of asymptomatic cases among new cases that develop during a period of 12 months
Percentage of asymptomatic cases among new cases (positive RT-qPCR or serological test) that develop during a period of 5 months
Measured: "Month 5" and "Month 12"
The proportion of asymptomatic cases among new cases that develop during a period of 12 months
Absolute number of asymptomatic cases among new cases (positive RT-qPCR or serological test) that develop during a period of 5 months
Measured: "Month 5" and "Month 12"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start22 Apr 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 SARS-CoV-2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciensano
- Sponsor type
- Other government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373889
- Sponsor's protocol ID
- Sciensano
- Acronym
- COVHECBEHO
- Status last verified
- Oct 2021
- First submitted
- 13 Apr 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortgat L, Verdonck K, Hutse V, Thomas I, Barbezange C, Heyndrickx L, Fischer N, Vuylsteke B, Kabouche I, Arien KK, Desombere I, Duysburgh E. Prevalence and incidence of anti-SARS-CoV-2 antibodies among healthcare workers in Belgian hospitals before vaccination: a prospective cohort study. BMJ Open. 2021 Jun 29;11(6):e050824. doi: 10.1136/bmjopen-2021-050824.
PubMed 34187832
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV-2 Prevalence, Seroprevalence and Seroconversion Among Healthcare Workers in Belgium During the 2020 COVID-19 Outbreak
- ClinicalTrials.gov ID
- NCT04373889
- Acronym / sponsor ID
- COVHECBEHO / Sciensano
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- SARS-CoV-2, COVID-19, Hospital healthcare workers, Belgium, Pandemic 2020, Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- SciensanoOther government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 May 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.
Due to the situation this study, originally planted until September 2020, was extended with 7 months until April 2021. This extension was approved by the ethical committee University hospital Ghent, Belgium.
The novel SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated Coronavirus type 2) is rapidly spreading over the world causing a condition called Coronavirus disease 2019 (COVID-19). Hospital health care workers (HCW) have received detailed instructions to protect themselves against this infection, but it is likely that at least some of the HCW will get infected either at their workplace or elsewhere. It would be useful to document prevalence and seroprevalence of SARS-CoV-2 and their monthly evolution among Belgian active hospital HCW during a period of 12 months starting beginning of April 2020 and the number of new cases (incidence) of COVID-19 and SARS-CoV-2 seroconversions among Belgian hospital HCW during a period of 12 months which are the primary objectives of this study.
Additionally the study will validate serological tests (subject to change/addition depending on the evolution of scientific research) against the plaque reduction neutralization test (PRNT) (gold standard); validate the saliva sample (sampling with Oracol or equivalent) against the standard naso/oro pharyngeal swabbing (NOPS) to perform RT-qPCR for SARS-CoV-2 diagnostic purposes, as well as against the standard serology (serum); validate the nasal swab against the standard (NOPS) to perform RT-qPCR for SARS-CoV-2 for diagnostic purposes; investigate potential risk factors for the infection; quantify the proportion of asymptomatic cases among new cases that develop during a period of 12 months.
To reach these primary and secondary objectives the researchers will conduct a prospective cohort study in which a random selection of HCW currently working in Belgian hospitals will be tested monthly (with for the first month an additional testing point at 14 days). The testing will include four kind of laboratory tests, being; a molecular (PCR) test on a nasopharyngeal, a saliva and nasal sample (for nasal and saliva sample only testing until 50 PCR positive and 50 PCR negative samples are collected) and a serological test for which a blood sample is needed. To asses risk factors, at each testing point a questionnaire providing basic socio-demographic and health characteristics of the HCW including presence of symptoms since the previous testing point and the HCW's involvement in caring for COVID-19 patients will be completed.
Laboratory data and epidemiological data (questionnaire) will be collected simultaneously. In each of the participating hospitals, one contact person will be designated to coordinate the study locally (ideally a staff member of the local infection and prevention control team) and communicate with the researchers. The sample size calculation indicated the inclusion of 17 randomly selected Belgian hospitals and in each hospital 50 randomly selected HCW. HCW can only be enrolled in the study after give a written informed consent.
Laboratory testing will be performed at the Virology Diseases and Immune Response services of Sciensano, Ukkel, and the Virology Laboratory of the Institute of Tropical Medicine, Antwerp. The laboratory test results will be communicated by the laboratory to each participant. Each participant and sample will have a unique code assigned. Data collected through the questionnaire will be send psuedonymised (using the unique code) to the epidemiologist at Sciensano. The laboratory will prepare a list of test results by unique code to be linked for further analysis with the questionnaire data. None of the researchers who will analyse the data will be involved in data collection, nor in the care of COVID-19 patients.
This study is a Belgian multicentric study executed by Sciensano, Brussels, in collaboration with the Institute of Tropical Medicine, Antwerp.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population include health care workers currently working in Belgian hospitals. According to current national guidelines, HCW in contact with persons at risk for COVID-19 experiencing mild respiratory symptoms without fever are allowed to work if clinical condition permits, while wearing a mask and observing usual hygiene measures. Healthcare workers experiencing respiratory symptoms and fever are systematically tested and if positive, isolated at home, if negative, eventually working wearing a mask if the clinical state allows it. Those who recovered from a documented infection are also allowed to work. HCW who are not in contact with persons at risk for COVID-19 are not tested and systematically isolated in case of any unusual respiratory symptom. This implies that at baseline, the study population will only include asymptomatic or paucisymptomatic HCW applying proper infection prevention measures.
Key inclusion criteria (3 listed)
- Any permanent medical and paramedical staff working in the hospital who provided a signed informed consent to participate in the study.
- Participants must have a social security insurance (mandatory in Belgium).
- This study only include adults.
Key exclusion criteria (3 listed)
- Staff hired on a temporary (interim) basis will be excluded as follow-up over time will be compromised.
- Administrative staff or technical staff will also be excluded.
- HCW who were not active during the inclusion period will automatically be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW)
Time frame: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in the percentage of HCW with positive RT-qPCR test on nasopharyngeal swabs among all HCW tested
Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW)
Time frame: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in the absolute number of HCW with positive RT-qPCR test on nasopharyngeal swabs among the total number of all HCW tested
Change of seroprevalence of SARS-CoV-2 among Belgian active hospital HCW
Time frame: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in percentage of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among all HCW tested
Change of seroprevalence of SARS-CoV-2 among Belgian active hospital HCW
Time frame: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in the absolute number of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among the total number of all HCW tested
Change in new cases (incidence) of COVID-19 among Belgian hospital HCW
Time frame: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in the percentage of HCW with positive RT-qPCR test on nasopharyngeal swabs among all HCW tested detected at each of the study follow-up testing points that did not have a positive RT-qPCR test before.
Change in new cases (incidence) of COVID-19 among Belgian hospital HCW
Time frame: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in absolute number of HCW with positive RT-qPCR test on nasopharyngeal swabs among the total number of HCW tested detected at each of the study follow-up testing points that did not have a positive RT-qPCR test before.
Change in SARS-CoV-2 seroconversion among Belgian hospital HCW
Time frame: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in the percentage of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among all HCW tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Change in SARS-CoV-2 seroconversion among Belgian hospital HCW
Time frame: "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"
Change in the absolute number of HCW with specific SARS-CoV-2 IgG/IgM detected in their serum by ELISA (positive SARS-CoV-2 serological test) among the total number of HCW tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
6 secondary outcomes
Sensitivity and specificity of serological tests
Time frame: "Month 3"
Sensitivity and specificity of saliva sampling method (sampling with Oracol or equivalent)
Time frame: "Month 3"
Validate the nasal swab against the standard
Time frame: "Month 3"
Potential risk factors for the infection
Time frame: "Month 5" and "Month 12"
The proportion of asymptomatic cases among new cases that develop during a period of 12 months
Time frame: "Month 5" and "Month 12"
The proportion of asymptomatic cases among new cases that develop during a period of 12 months
Time frame: "Month 5" and "Month 12"
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 4 Oct 2021.
- Derived from this study: PubMed 34187832Mortgat L, Verdonck K, Hutse V, Thomas I, Barbezange C, Heyndrickx L, Fischer N, Vuylsteke B, Kabouche I, Arien KK, Desombere I, Duysburgh E. Prevalence and incidence of anti-SARS-CoV-2 antibodies among healthcare workers in Belgian hospitals before vaccination: a prospective cohort study. BMJ Open. 2021 Jun 29;11(6):e050824. doi: 10.1136/bmjopen-2021-050824.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by Sciensano 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 3 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 4 Oct 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?
Change of prevalence of COVID-19 infection among Belgian active hospital healthcare workers (HCW) (time frame: "Day 1", "Week 2", "Week 4", "Month 2", "Month 3", "Month 4", "Month 5", "Month 6", "Month 7", "Month 8", "Month 9", "Month 10", "Month 11" and "Month 12"). The study lists 8 primary outcomes in all. 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 NCT04373889, 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 4 Oct 2021.