COVID-19NCT04356586
Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms
An observational study of COVID-19 and Serology, run by Sciensano at 1 site in Belgium.
Trial summary
Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- How many people
- 287 participants
- Where
- 1 siteBelgium
- Study dates
- 4 May 2020to 21 Aug 2020
- How long will I take part?
- 3 Months
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium
Who may be able to join
- HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs.
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of serological positive healthcare workers
Measured: three months
Percentage of HCW with positive Saliva-sabs
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start4 May 2020
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 287 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sciensano
- Sponsor type
- Other government
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Maria Gpossens, Sciensano
- Investigators
- Maria Goossens, MD, PhD, Principal investigator, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356586
- Sponsor's protocol ID
- Jessa300
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms
- ClinicalTrials.gov ID
- NCT04356586
- Acronym / sponsor ID
- Jessa300
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- SciensanoOther government
- Collaborators
- Jessa Hospital
- Study start
- 4 May 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 22 Apr 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.
Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium
Key inclusion criteria (1 listed)
- HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium
Key exclusion criteria (1 listed)
- -
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
Percentage of serological positive healthcare workers
Time frame: three months
Percentage of HCW with positive Saliva-sabs
Time frame: three months
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 7 Sep 2020.
- 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.
Maria Goossens, MD, PhD principal investigator
Sciensano
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 COVID-19 and Serology, 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 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 7 Sep 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?
Percentage of serological positive healthcare workers (time frame: three months). 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 7 Sep 2020.