Sars-CoV2EXPOCOVIANCT04371692
Prevalence of COVID-19 Infection Among HCW in a French University Hospital
An observational study of Sars-CoV2, run by University Hospital, Lille at 1 site in France.
Trial summary
The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants. 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?
- self-administered questionnaire and SARS-Cov2 testing
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 9 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health Care workers with or without symptoms suggestive of a COVID-19 infection
Who may be able to join
- Health Care workers with or without symptoms suggestive of a COVID-19 infection
Who cannot join
- HCW working off-site at the CHU de Lille
- HCW on sick leave.
- HCW outside the Lille University Hospital temporarily coming as reinforcements in the context of the epidemic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of SARS-Cov2 Infection Among HCW in Lille University Hospital
The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.
- Conditions
- Sars-CoV2
- Being tested
- self-administered questionnaire, SARS-Cov2 testing
- Keywords
- Prevalence, Health Care Workers, occupational exposure, environmental exposure, serological testing, RT-PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered questionnaireOther
Also called a specifically designed self-administered questionnaire
Every weeks during 2 months, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure
SARS-Cov2 testingDiagnostic test
Every weeks during 2 month, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure
| Study group | Role | What they receive |
|---|---|---|
| High-risk | staff working in a unit specifically for patients infected or suspected of being infected with SARS-Cov2 Receives: Other: self-administered questionnaire; Diagnostic Test: SARS-Cov2 testing | |
| Medium- risk | staff working in a unit that can accommodate patients infected or suspected of being infected with SARS-Cov2, i.e., all care services that do not fall into the high-risk group. Receives: Other: self-administered questionnaire; Diagnostic Test: SARS-Cov2 testing | |
| Low-risk | off-patient staff Receives: Other: self-administered questionnaire; Diagnostic Test: SARS-Cov2 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection
Measured: at 2 months
Secondary outcomes (5)
the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection
Measured: once week during 2 months
Occupational exposures associated with the SARS-Cov2 infection
Measured: once week during 2 months
Environmental exposures associated with the SARS-Cov2 infection
Measured: once week during 2 months
immunologic status of health Care Worker
Measured: once week during 2 months
inflammatory biomarkers status of Health Care Worker
Measured: once week during 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start15 Jun 2020
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
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 University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Santé Roquette
- Responsible party
- Sponsor
- Investigators
- Annie SOBASZEK, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371692
- Sponsor's protocol ID
- 2020_35
- Other IDs
- 2020-A00951-38
- Acronym
- EXPOCOVIA
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of SARS-Cov2 Infection Among HCW in Lille University Hospital
- ClinicalTrials.gov ID
- NCT04371692
- Acronym / sponsor ID
- EXPOCOVIA / 2020_35
- Conditions
- Sars-CoV2
- Keywords
- Prevalence, Health Care Workers, occupational exposure, environmental exposure, serological testing, RT-PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Fondation Santé Roquette
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 1 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.
The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-risk | – | Other: self-administered questionnaire, Diagnostic Test: SARS-Cov2 testingstaff working in a unit specifically for patients infected or suspected of being infected with SARS-Cov2 |
| Medium- risk | – | Other: self-administered questionnaire, Diagnostic Test: SARS-Cov2 testingstaff working in a unit that can accommodate patients infected or suspected of being infected with SARS-Cov2, i.e., all care services that do not fall into the high-risk group. |
| Low-risk | – | Other: self-administered questionnaire, Diagnostic Test: SARS-Cov2 testingoff-patient staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health Care workers with or without symptoms suggestive of a COVID-19 infection
Key inclusion criteria (1 listed)
- Health Care workers with or without symptoms suggestive of a COVID-19 infection
Key exclusion criteria (3 listed)
- HCW working off-site at the CHU de Lille
- HCW on sick leave.
- HCW outside the Lille University Hospital temporarily coming as reinforcements in the context of the epidemic.
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 |
|---|---|---|
| self-administered questionnaireAlso: a specifically designed self-administered questionnaireEvery weeks during 2 months, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure | Other | High-risk, Low-risk, Medium- risk |
| SARS-Cov2 testingEvery weeks during 2 month, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure | Diagnostic test | High-risk, Low-risk, Medium- risk |
Primary outcome
the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection
Time frame: at 2 months
5 secondary outcomes
the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection
Time frame: once week during 2 months
Occupational exposures associated with the SARS-Cov2 infection
Time frame: once week during 2 months
Environmental exposures associated with the SARS-Cov2 infection
Time frame: once week during 2 months
immunologic status of health Care Worker
Time frame: once week during 2 months
inflammatory biomarkers status of Health Care Worker
Time frame: once week during 2 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 23 Apr 2021.
Related trials for Sars-CoV2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Annie SOBASZEK, MD principal investigator
University Hospital, Lille
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-CoV2, run by University Hospital, Lille at 1 site 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 1 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 23 Apr 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 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?
the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection (time frame: at 2 months). 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 23 Apr 2021.