Covid19CovAbNCT04503447
COVID-19 Seroprevalence Study in ITM Staff
An observational study of Covid19, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial summary
In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its second wave. The Belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 330 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2020to 9 Sep 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Active ITM staff members
Who may be able to join
- Be an active ITM staff member
- Be willing and able to complete the questionnaire
- Be willing and able to provide informed consent
Who cannot join
- Doctor of Philosophy (PhD) students, Master students and interns of the ITM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severe Acute Respiratory Syndrome Coronavirus (CoV) 2 (SARS-CoV-2) Seroprevalence Study in Institute of Tropical Medicine (ITM) Staff
In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its second wave.
The Belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. To decide which containment measures should be maintained, reinstalled or suspended, information on what proportion of people has been infected and on possible risk factors for virus transmission can be helpful.
This study will be conducted on staff members of the ITM. All staff members will be invited to participate. Participants will be asked to have a blood sample drawn for detections of antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2 ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to complete a questionnaire about their exposure, both within and outside the ITM, to the SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.
Read the detailed description
The study is observational and will be conducted on ITM staff members. All members will be invited to participate.
- Conditions
- Covid19
- Keywords
- humans, COVID-19, pandemics, SARS virus, cross-sectional studies, seroepidemiological studies, Belgium, risk factors, seroprevalence
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 seroprevalence ITM staff
The proportion of participating ITM staff members with detectable SARS-CoV-2 antibodies
Measured: Sample is drawn once, within 7 days after recruitment
Secondary outcomes (1)
SARS-CoV-2 seroprevalence in ITM staff, stratified by variables
SARS-CoV-2 seroprevalence in ITM staff members stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.
Measured: Questionnaire is completed once, at recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2020
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjan Van Esbroeck, MD, Principal investigator, Institute of Tropical Medicine, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503447
- Sponsor's protocol ID
- SARSCOV2SEROPREVALENCEITMSTAFF
- Acronym
- CovAb
- Status last verified
- Sep 2020
- First submitted
- 4 Aug 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study population being only ITM staff members, individual participant data (IPD) cannot be shared due to privacy reasons
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Acute Respiratory Syndrome Coronavirus (CoV) 2 (SARS-CoV-2) Seroprevalence Study in Institute of Tropical Medicine (ITM) Staff
- ClinicalTrials.gov ID
- NCT04503447
- Acronym / sponsor ID
- CovAb / SARSCOV2SEROPREVALENCEITMSTAFF
- Conditions
- Covid19
- Keywords
- humans, COVID-19, pandemics, SARS virus, cross-sectional studies, seroepidemiological studies, Belgium, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 7 Aug 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.
In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its second wave.
The Belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. To decide which containment measures should be maintained, reinstalled or suspended, information on what proportion of people has been infected and on possible risk factors for virus transmission can be helpful.
This study will be conducted on staff members of the ITM. All staff members will be invited to participate. Participants will be asked to have a blood sample drawn for detections of antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2 ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to complete a questionnaire about their exposure, both within and outside the ITM, to the SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.
Detailed description
The study is observational and will be conducted on ITM staff members. All members will be invited to participate.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Active ITM staff members
Key inclusion criteria (3 listed)
- Be an active ITM staff member
- Be willing and able to complete the questionnaire
- Be willing and able to provide informed consent
Key exclusion criteria (1 listed)
- Doctor of Philosophy (PhD) students, Master students and interns of the ITM
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
SARS-CoV-2 seroprevalence ITM staff
Time frame: Sample is drawn once, within 7 days after recruitment
The proportion of participating ITM staff members with detectable SARS-CoV-2 antibodies
1 secondary outcome
SARS-CoV-2 seroprevalence in ITM staff, stratified by variables
Time frame: Questionnaire is completed once, at recruitment
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 22 Oct 2020.
- Individual participant dataSharing planned: No. Study population being only ITM staff members, individual participant data (IPD) cannot be shared due to privacy reasons
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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.
Marjan Van Esbroeck, MD principal investigator
Institute of Tropical Medicine, Belgium
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 Covid19, run by Institute of Tropical Medicine, Belgium 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 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 22 Oct 2020. 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?
SARS-CoV-2 seroprevalence ITM staff (time frame: Sample is drawn once, within 7 days after recruitment). 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 22 Oct 2020.