Covid19POCAH-COVIDNCT04548908
Prevalence Of COVID-19 Among Health-workers in a French General Hospital
An observational study of Covid19, run by Centre Hospitalier Sud Essonne at 1 site in France.
Trial summary
The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Serelogy testing, RT PCR
- How many people
- 1,300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2020to 30 Jun 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
- Adult, Older adult
Study population: Adult healthcare workers who are not opposed to participate to the research
Who may be able to join
- hospital staff working at the Centre Hospitalier Sud Essonne,
- employed by the Centre Hospitalier Sud Essonne between March, 5th, 2020, and August, 31rst, 2020,
- with the result of an RT PCR test or a serologic test,
- this (these) result(s) must have been/be communicated to the occupational health service of the hospital.
Who cannot join
- interim workers,
- workers in holidays during the entire period of inclusion above,
- opposition to participate in this study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sud Essonne
Étampes, 91150
Delphine LEMAIRE-BRUNEL, 01 60 80 79 88 ext. + 33, dlemaire-brunel@ch-sudessonne.fr
About this study
The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.
Read the detailed description
Since December 2019, the COVID-19 pandemic has widespread from China and put under strong tension the health organizations throughout the world, especially since march 2020 in France.
As a consequence, the French hospitals had to cope with a massive amount of COVID-19 infected patients and, thus, their organisations had to evolve in order to be able to admit more patients in their critical care units.
First studies reported an important level of inter-human contagiousness of the SARS-CoV-2 virus with an "R0" (basic reproduction number) superior to 3, which could lead to a massive contamination of healthcare workers since they are directly in charge of infected patients.
Other studies suggested that the healthcare workers are more likely to be contaminated by the COVID-19 than the rest of the population, which pushed governments and hospital managers to put in place individual and collective measures of protection in order to avoid nosocomial transmissions and also to preserve the health of the hospital staffs in a context of high tension on the hospital work force.
There are today few data about the contamination level among the healthcare workers of general hospitals in France and about the severity of these contaminations. A national study is being conducted but on a macroscopic regional scale. In addition to that, the proportion of asymptomatic SARS-CoV-2 contaminated healthcare workers is not known as well as the origin (hospital or community) of the contaminations.
In June 2020, the French Health Ministry decided to launch a collection of epidemiological data in the French hospitals based on serologic tests. Thanks to this action and with the results of all the RT PCR tests systematically conducted since the beginning of the pandemic when a healthcare worker had COVID-19-like symptoms, the Centre Hospitalier Sud Essonne has decided to conduct an observational study.
The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.
- Conditions
- Covid19
- Being tested
- Serelogy testing, RT PCR
- Keywords
- health-workers, COVID19, hospital, SARS-CoV-2, prevalence
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serelogy testing, RT PCRDiagnostic test
Serology testing for all the participants and RT PCR for participants with symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
General prevalence of COVID-19
measures the prevalence of COVID-19 among the healthcare workers of the Centre Hospitalier Sud Essonne, defined as the hospital employees with positive serologic or RT-PCR tests.
It must be underlined that the notion of "health workers" include the entire hospital staff ie doctors, nurses, administrative employees,...
Measured: Through study completion, an average of 9 months
Secondary outcomes (5)
Number of asymptomatic healthcare workers
- no RT PCR or negative RT PCR and positive serologic test,
- positive RT PCR and no symptoms,
Measured: Through study completion, an average of 9 months
Number of symptomatic healthcare workers
Positive RT-PCR test or serologic test with symptoms.
Measured: Through study completion, an average of 9 months
Number of healthcare workers with a severe form of COVID-19 which led to an hospitalization
Positive serologic or RTC-PCR test and hospitalization
Measured: Through study completion, an average of 9 months
Number of healthcare workers infected with COVID-19 and hospitalized in a critical care unit
Positive serologic or RTC-PCR test and hospitalization in a critical care unit
Measured: Through study completion, an average of 9 months
Influencing factors of the prevalence of the COVID-19 among healthcare workers
- age,
- gender,
- job,
- duration of employment in the hospital,
- hospital site of affectation,
- unit of affectation.
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start3 Aug 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
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
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Essonne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine LEMAIRE-BRUNEL, Principal investigator, Centre Hospitalier Sud Essonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548908
- Sponsor's protocol ID
- POCAH-COVID19
- Acronym
- POCAH-COVID
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of COVID-19 Among Health-workers in a French General Hospital
- ClinicalTrials.gov ID
- NCT04548908
- Acronym / sponsor ID
- POCAH-COVID / POCAH-COVID19
- Conditions
- Covid19
- Keywords
- health-workers, COVID19, hospital, SARS-CoV-2, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud EssonneUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 16 Sep 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 aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.
Detailed description
Since December 2019, the COVID-19 pandemic has widespread from China and put under strong tension the health organizations throughout the world, especially since march 2020 in France.
As a consequence, the French hospitals had to cope with a massive amount of COVID-19 infected patients and, thus, their organisations had to evolve in order to be able to admit more patients in their critical care units.
First studies reported an important level of inter-human contagiousness of the SARS-CoV-2 virus with an "R0" (basic reproduction number) superior to 3, which could lead to a massive contamination of healthcare workers since they are directly in charge of infected patients.
Other studies suggested that the healthcare workers are more likely to be contaminated by the COVID-19 than the rest of the population, which pushed governments and hospital managers to put in place individual and collective measures of protection in order to avoid nosocomial transmissions and also to preserve the health of the hospital staffs in a context of high tension on the hospital work force.
There are today few data about the contamination level among the healthcare workers of general hospitals in France and about the severity of these contaminations. A national study is being conducted but on a macroscopic regional scale. In addition to that, the proportion of asymptomatic SARS-CoV-2 contaminated healthcare workers is not known as well as the origin (hospital or community) of the contaminations.
In June 2020, the French Health Ministry decided to launch a collection of epidemiological data in the French hospitals based on serologic tests. Thanks to this action and with the results of all the RT PCR tests systematically conducted since the beginning of the pandemic when a healthcare worker had COVID-19-like symptoms, the Centre Hospitalier Sud Essonne has decided to conduct an observational study.
The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult healthcare workers who are not opposed to participate to the research
Key inclusion criteria (4 listed)
- hospital staff working at the Centre Hospitalier Sud Essonne,
- employed by the Centre Hospitalier Sud Essonne between March, 5th, 2020, and August, 31rst, 2020,
- with the result of an RT PCR test or a serologic test,
- this (these) result(s) must have been/be communicated to the occupational health service of the hospital.
Key exclusion criteria (3 listed)
- interim workers,
- workers in holidays during the entire period of inclusion above,
- opposition to participate in this study.
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 |
|---|---|---|
| Serelogy testing, RT PCRSerology testing for all the participants and RT PCR for participants with symptoms | Diagnostic test | – |
Primary outcome
General prevalence of COVID-19
Time frame: Through study completion, an average of 9 months
measures the prevalence of COVID-19 among the healthcare workers of the Centre Hospitalier Sud Essonne, defined as the hospital employees with positive serologic or RT-PCR tests. It must be underlined that the notion of "health workers" include the entire hospital staff ie doctors, nurses, administrative employees,...
5 secondary outcomes
Number of asymptomatic healthcare workers
Time frame: Through study completion, an average of 9 months
Number of symptomatic healthcare workers
Time frame: Through study completion, an average of 9 months
Number of healthcare workers with a severe form of COVID-19 which led to an hospitalization
Time frame: Through study completion, an average of 9 months
Number of healthcare workers infected with COVID-19 and hospitalized in a critical care unit
Time frame: Through study completion, an average of 9 months
Influencing factors of the prevalence of the COVID-19 among healthcare workers
Time frame: Through study completion, an average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
Delphine LEMAIRE-BRUNEL principal investigator
Centre Hospitalier Sud Essonne
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, run by Centre Hospitalier Sud Essonne 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 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: status not confirmed, as of the sponsor's last update on 16 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 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 Delphine LEMAIRE-BRUNEL (01 60 80 79 88 ext. +33, dlemaire-brunel@ch-sudessonne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General prevalence of COVID-19 (time frame: Through study completion, an average of 9 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 16 Sep 2020.