Covid19PACAAPNCT04845984
Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Four Hospital of the Alpine Region
An observational study of Covid19 and Health Care Worker, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Health Care Worker
- How many people
- 3,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 15 Jan 2021
- 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: The study will be proposed to all the staff of participating hospitals, who have been tested for SARS-CoV-2 (serology) and who have not objected to the use of their health data.
Who may be able to join
- Hospital staff employee
- Employed in one of the participating centers
- Volunteers to perform SARS-CoV-2 serology
- Permanent or occasional staff (temporary workers, short contracts)
- Caregivers or not (medical, paramedical, administrative, technical staff)
Who cannot join
- Staff who are not working at a participating center while participating in the study
- Person under guardianship or curatorship
- Opposition to data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Five Hospital of the Alpine Region
The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.
Read the detailed description
In France during the first wave of the pandemic, 30,230 symptomatic healthcare workers had been reported positive. Yet, the prevalence of the infection in French healthcare workers remains unknown as it mostly reflect symptomatic infections.
Also, the prevalence of infection was reported being higher in male healthcare workers, and in those having patients' facing roles. However, the impact of the level of exposure to SARS-CoV-2, the use of personal protective equipment and hospital organization to prevent infection and spread remains unclear.
Our study aims to report the seroprevalence of SARS-CoV-2 infection among French healthcare workers after the first wave of the pandemic. It also aims to explore the impact of the type of occupations and the level of exposure to the viruses on the seroprevalence of infection.
- Conditions
- Covid19, Health Care Worker
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 prevalency among hospital health care professionals
Number of Health Care Worker with an antibody test (IgG) positive for SARS-CoV2
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Sep 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845984
- Sponsor's protocol ID
- 20-12
- Acronym
- PACAAP
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 15 Apr 2021
- 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Five Hospital of the Alpine Region
- ClinicalTrials.gov ID
- NCT04845984
- Acronym / sponsor ID
- PACAAP / 20-12
- Conditions
- Covid19, Health Care Worker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 15 Apr 2021 (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 PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.
Detailed description
In France during the first wave of the pandemic, 30,230 symptomatic healthcare workers had been reported positive. Yet, the prevalence of the infection in French healthcare workers remains unknown as it mostly reflect symptomatic infections.
Also, the prevalence of infection was reported being higher in male healthcare workers, and in those having patients' facing roles. However, the impact of the level of exposure to SARS-CoV-2, the use of personal protective equipment and hospital organization to prevent infection and spread remains unclear.
Our study aims to report the seroprevalence of SARS-CoV-2 infection among French healthcare workers after the first wave of the pandemic. It also aims to explore the impact of the type of occupations and the level of exposure to the viruses on the seroprevalence of infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be proposed to all the staff of participating hospitals, who have been tested for SARS-CoV-2 (serology) and who have not objected to the use of their health data.
Key inclusion criteria (5 listed)
- Hospital staff employee
- Employed in one of the participating centers
- Volunteers to perform SARS-CoV-2 serology
- Permanent or occasional staff (temporary workers, short contracts)
- Caregivers or not (medical, paramedical, administrative, technical staff)
Key exclusion criteria (3 listed)
- Staff who are not working at a participating center while participating in the study
- Person under guardianship or curatorship
- Opposition to data collection
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 prevalency among hospital health care professionals
Time frame: Day 1
Number of Health Care Worker with an antibody test (IgG) positive for SARS-CoV2
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 15 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Health Care Worker, run by Centre Hospitalier Annecy Genevois 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 5 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 15 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?
SARS-CoV-2 prevalency among hospital health care professionals (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 15 Apr 2021.