COVID-19SERODRONNCT04429724
Health Professional Exposure Assessment to Covid-19
A study testing Diagnostic test Covid-19 in people with COVID-19, run by Tourcoing Hospital at 4 sites in France.
Trial summary
Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Diagnostic test Covid-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,129 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Jul 2020to 16 Mar 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
- Staff on duty in the health facility
- Eligible to be drawn
- Beneficiary subject affiliated or entitled to a social security scheme
Who cannot join
- Minor patient
- Refusal to participate
- Patient under guardianship
- Patient under guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Roubaix
Roubaix
CH Tourcoing
Tourcoing
CH Wasquehal
Wasquehal
CH Wattrelos
Wattrelos
About this study
Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.
Read the detailed description
This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.
Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.
In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.
- Conditions
- COVID-19
- Being tested
- Diagnostic test Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test Covid-19Diagnostic test
Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.
| Study group | Role | What they receive |
|---|---|---|
| health workers at hospital | Experimental | Three blood samples will be taken at day 1, month 3 and month 6. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6. Receives: Diagnostic Test: Diagnostic test Covid-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contaminated personnel
Number of contaminated personnel by occupational category and department on day 1.
Measured: day 1
Secondary outcomes (6)
Number of contaminated personnel
Number of contaminated personnel by professional category and by service at month 3 a by serological test
Measured: month 3
Number of contaminated personnel
Number of contaminated personnel by professional category and by service at month 6 a by serological test
Measured: month 6
Number of symptomatic staff by occupational category and service
Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS
Measured: month 3
Number of symptomatic staff by occupational category and service
Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS
Measured: month 6
Number of contaminated personnel with effective protection
Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6
Measured: evolution at day 1, month 3 and month 6
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start6 Jul 2020
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PATOZ Pierre, PharmD, Principal investigator, CH TOURCOING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429724
- Sponsor's protocol ID
- RIPH_2020_8
- Acronym
- SERODRON
- Status last verified
- May 2022
- First submitted
- 10 Jun 2020
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Professional Exposure Assessment to Covid-19
- ClinicalTrials.gov ID
- NCT04429724
- Acronym / sponsor ID
- SERODRON / RIPH_2020_8
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,129 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 12 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.
Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.
Detailed description
This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.
Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.
In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health workers at hospital | Experimental | Diagnostic Test: Diagnostic test Covid-19Three blood samples will be taken at day 1, month 3 and month 6. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Staff on duty in the health facility
- Eligible to be drawn
- Beneficiary subject affiliated or entitled to a social security scheme
Key exclusion criteria (4 listed)
- Minor patient
- Refusal to participate
- Patient under guardianship
- Patient under guardianship
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 |
|---|---|---|
| Diagnostic test Covid-19Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6. | Diagnostic test | health workers at hospital |
Primary outcome
Number of contaminated personnel
Time frame: day 1
Number of contaminated personnel by occupational category and department on day 1.
6 secondary outcomes
Number of contaminated personnel
Time frame: month 3
Number of contaminated personnel
Time frame: month 6
Number of symptomatic staff by occupational category and service
Time frame: month 3
Number of symptomatic staff by occupational category and service
Time frame: month 6
Number of contaminated personnel with effective protection
Time frame: evolution at day 1, month 3 and month 6
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies
Time frame: month 6
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 10 May 2022.
- 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.
PATOZ Pierre, PharmD principal investigator
CH TOURCOING
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test Covid-19 in people with COVID-19, run by Tourcoing Hospital at 4 sites in France.
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 4 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Number of contaminated personnel (time frame: day 1). 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 10 May 2022.