COVID-19FP-COVID-19NCT05616663
Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Started on January 9, 2020 with the announcement of the discovery of a new SARS-CoV-2 coronavirus, the Covid-19 pandemic is responsible as of June 21, 2020 for 160,377 confirmed cases in France, 29,640 deaths and 9,823 hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 639 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2020to 16 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Professional rom the University Hospitals of Strasbourg (HUS) who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.
Who may be able to join
- Major subject (≥18 years old)
- Professionals from the University Hospitals of Strasbourg (HUS)
- Professionals who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.
- Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes
Who cannot join
- Subject who expressed their opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pathologie Professionnelle et Médecine du Travail - CHU de Strasbourg - France
Strasbourg, 67091
Maria GONZALEZ, MD, PhD, 33 3 88 11 64 66, maria.gonzalez@chru-strasbourg.fr
Maria GONZALEZ, MD, PhD
About this study
Official title: SARS-COV-2 Infection Among Hospital Staff: Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work
Started on January 9, 2020 with the announcement of the discovery of a new SARS-CoV-2 coronavirus, the Covid-19 pandemic is responsible as of June 21, 2020 for 160,377 confirmed cases in France, 29,640 deaths and 9,823 hospitalizations. The Grand Est region is one of the regions in France that was most precociously and strongly affected by the epidemic, in particular the Strasbourg University Hospital. Faced with the heavy use of the healthcare system, hospital staff of all categories are an essential resource to be preserved. Several studies have shown the significant impact of Covid-19 on doctors and caregivers. In order to better protect these personnel and avoid contamination that could be harmful to their health but also because of the consequences in terms of staff, it is necessary to better understand the risk factors for transmission of this infection, the means of protection, the evolution of the disease and the determinants of the return to work. Few studies have explored on such a large workforce and in detail the professional risk factors for developing Covid-19 within different groups of hospital professionals including also non-caregivers and the evolution when returning to work in an outpatient population.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
positive RT-PCR test
The presence of SARS CoV 2 infection is assessed by a positive RT-PCR test
Measured: one week after infection with Covid-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start31 Jul 2020
- Primary completion16 Dec 2023 (estimated)
- Study completion16 Dec 2023 (estimated)
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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 639 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616663
- Sponsor's protocol ID
- 7954
- Acronym
- FP-COVID-19
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2022
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV-2 Infection Among Hospital Staff: Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work
- ClinicalTrials.gov ID
- NCT05616663
- Acronym / sponsor ID
- FP-COVID-19 / 7954
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 639 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- 16 Dec 2023 (estimated)
- First posted
- 15 Nov 2022 (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.
Started on January 9, 2020 with the announcement of the discovery of a new SARS-CoV-2 coronavirus, the Covid-19 pandemic is responsible as of June 21, 2020 for 160,377 confirmed cases in France, 29,640 deaths and 9,823 hospitalizations. The Grand Est region is one of the regions in France that was most precociously and strongly affected by the epidemic, in particular the Strasbourg University Hospital. Faced with the heavy use of the healthcare system, hospital staff of all categories are an essential resource to be preserved. Several studies have shown the significant impact of Covid-19 on doctors and caregivers. In order to better protect these personnel and avoid contamination that could be harmful to their health but also because of the consequences in terms of staff, it is necessary to better understand the risk factors for transmission of this infection, the means of protection, the evolution of the disease and the determinants of the return to work. Few studies have explored on such a large workforce and in detail the professional risk factors for developing Covid-19 within different groups of hospital professionals including also non-caregivers and the evolution when returning to work in an outpatient population.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Professional rom the University Hospitals of Strasbourg (HUS) who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.
Key inclusion criteria (4 listed)
- Major subject (≥18 years old)
- Professionals from the University Hospitals of Strasbourg (HUS)
- Professionals who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.
- Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes
Key exclusion criteria (1 listed)
- Subject who expressed their opposition to participating in the study
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
positive RT-PCR test
Time frame: one week after infection with Covid-19
The presence of SARS CoV 2 infection is assessed by a positive RT-PCR test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
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, run by University Hospital, Strasbourg, France 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 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria GONZALEZ, MD, PhD (33 3 88 11 64 66, maria.gonzalez@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive RT-PCR test (time frame: one week after infection with Covid-19). 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 8 Dec 2023.