COVID-19HOP-COVIDNCT04386759
COVID-19 Infection in Healthcare Workers
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Introduction: The SARS-Cov-2 outbreak in France and the concomitant massive increase in the number of cases requiring hospital management create a major risk of COVID-19 infection for hospital staff. 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?
- Cohort
- How many people
- 1,858 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2020to 26 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults healthcare workers, who are not opposed to participating in research.
Who may be able to join
- Hospital staff working in any of the 5 hospitals participating in the study,
- Of legal age,
- With or without a previous diagnosis of COVID-19 infection,
- Patient with a SARS-CoV-2 screening by RT-PCR or antigenic test (from version 3.0 of the protocol)
- Not opposed to participating in the research
Who cannot join
- Unable or unwilling to complete the non-opposition
- Unable or unwilling to complete an online self-questionnaire (eCRF)
- Opposition to participate in research
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, 94 010
About this study
Official title: COVID-19 Infection in Healthcare Workers: a Cohort Study
Introduction: The SARS-Cov-2 outbreak in France and the concomitant massive increase in the number of cases requiring hospital management create a major risk of COVID-19 infection for hospital staff. In addition to nosocomial transmission, the health care workers (HCWs), defined as persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials, are also exposed to community transmission. Whether HCWs acquire infection at work or in the community is important to adapt protection measures. A few studies investigated COVID-19 infection among medical and nursing personnel. However, none have analyzed all categories of hospital staff. As of April 9, 2020, a total of 9,282 US HCWs with confirmed COVID-19 had been reported to CDC (US), however description of occupational activities was not available. Therefore, limited information is available about COVID-19 infection among HCWs.
Thus, the objectives of the sdudy are to estimate the incidence of symptomatic SARS-CoV-2 infection in HCWs in five university hospitals (including geriatric hospitals) of the great Paris area and to estimate both nosocomial and community risk factors.
Read more
Method: A prospective and retrospective cohort study that includes all hospital staff (including medical and nursing personnel, health care managers, laboratory, radiology, reception staffs, stretcher-bearers, etc.) working in different departments of five university hospitals (acute medical centers and geriatric hospitals) in the great Paris area (9 000 HCWs). Incidence of symptomatic SARS-CoV-2 infection will be estimated with its 95%CI. Individual and contextual risk factors will be analyzed using multilevel multivariate logistic regression modelling to account for clustering and confounding.
Conclusion This study should make it possible to better characterize SARS-Cov-2 contamination of HCWs and to estimate the share of nosocomial transmission.
Read the detailed description
Details for "Study design" section
Time perspective : Retrospective and prospective cohort study.
Up to protocol v2.0: Data from healthcare workers with COVID+ diagnostic at the time of inclusion will only be collected retrospectively. In contrast, data from healthcare workers free from infection will be collected prospectively.
From protocol v3.0: Recruitment of healthcare workers will be prospective. A retrospective collection of exposures during the 15 days preceding the RT-PCR or the antigenic test for COVID diagnosis will be performed.
- Conditions
- COVID-19
- Being tested
- Cohort
- Keywords
- COVID-19, Healthcare workers, Incidence, Risk factors, Nosocomial infection
- Medical subject headings
- COVID-19, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortOther
None. Only implementation of a cohort with data collection via individual self-questionnaires and administrative services for contextual data.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | Up to protocol v2.0: Filling when including a first self-survey concerning the period of the last fifteen days. The following questionnaires will be completed online every week until the end of the study. For healthcare worker who have already presented a symptomatic infection at the time of inclusion, only the self-survey "inclusion" will be completed, it will relate to the period of fifteen days preceding the diagnosis.
From protocol v3.0: After performing a RT-PCR or an antigenic test for COVID diagnosis, the healthcare workers will complete a unique self-questionnaire about individual and contextual risks factors during the 15 days preceding the test. Receives: Other: Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-COV-2 infection
The primary endpoint will be the occurrence of confirmed (RT-PCR or antigenic test or work stopping) SARS-CoV-2 infection.
Measured: Up to 3 months
Secondary outcomes (2)
SARS-COV-2 incidence regarding hospitals, assigned services and profession
Information collected by a self questionnaire and service datas
Measured: Up to 3 months maximum
Individual and contextual risks factors
Risks factor are collected by a self questionnaire and service datas
Measured: Up to 3 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start18 May 2020
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Enrolment
- 1,858 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie BASTUJI-GARIN, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386759
- Sponsor's protocol ID
- APHP200483
- Acronym
- HOP-COVID
- Status last verified
- Aug 2021
- First submitted
- 30 Apr 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.
Publications
Bastuji-Garin S, Brouard L, Bourgeon-Ghittori I, Zebachi S, Boutin E, Hemery F, Fourreau F, Oubaya N, De Roux Q, Mongardon N, Fourati S, Decousser JW. The Relative Contributions of Occupational and Community Risk Factors for COVID-19 among Hospital Workers: The HOP-COVID Cohort Study. J Clin Med. 2023 Feb 2;12(3):1208. doi: 10.3390/jcm12031208.
PubMed 36769854
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Infection in Healthcare Workers: a Cohort Study
- ClinicalTrials.gov ID
- NCT04386759
- Acronym / sponsor ID
- HOP-COVID / APHP200483
- Conditions
- COVID-19
- Keywords
- COVID-19, Healthcare workers, Incidence, Risk factors, Nosocomial infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,858 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 13 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.
Introduction: The SARS-Cov-2 outbreak in France and the concomitant massive increase in the number of cases requiring hospital management create a major risk of COVID-19 infection for hospital staff. In addition to nosocomial transmission, the health care workers (HCWs), defined as persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials, are also exposed to community transmission. Whether HCWs acquire infection at work or in the community is important to adapt protection measures. A few studies investigated COVID-19 infection among medical and nursing personnel. However, none have analyzed all categories of hospital staff. As of April 9, 2020, a total of 9,282 US HCWs with confirmed COVID-19 had been reported to CDC (US), however description of occupational activities was not available. Therefore, limited information is available about COVID-19 infection among HCWs.
Thus, the objectives of the sdudy are to estimate the incidence of symptomatic SARS-CoV-2 infection in HCWs in five university hospitals (including geriatric hospitals) of the great Paris area and to estimate both nosocomial and community risk factors.
Method: A prospective and retrospective cohort study that includes all hospital staff (including medical and nursing personnel, health care managers, laboratory, radiology, reception staffs, stretcher-bearers, etc.) working in different departments of five university hospitals (acute medical centers and geriatric hospitals) in the great Paris area (9 000 HCWs). Incidence of symptomatic SARS-CoV-2 infection will be estimated with its 95%CI. Individual and contextual risk factors will be analyzed using multilevel multivariate logistic regression modelling to account for clustering and confounding.
Conclusion This study should make it possible to better characterize SARS-Cov-2 contamination of HCWs and to estimate the share of nosocomial transmission.
Detailed description
Details for "Study design" section
Time perspective : Retrospective and prospective cohort study.
Up to protocol v2.0: Data from healthcare workers with COVID+ diagnostic at the time of inclusion will only be collected retrospectively. In contrast, data from healthcare workers free from infection will be collected prospectively.
From protocol v3.0: Recruitment of healthcare workers will be prospective. A retrospective collection of exposures during the 15 days preceding the RT-PCR or the antigenic test for COVID diagnosis will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Other: CohortUp to protocol v2.0: Filling when including a first self-survey concerning the period of the last fifteen days. The following questionnaires will be completed online every week until the end of the study. For healthcare worker who have already presented a symptomatic infection at the time of inclusion, only the self-survey "inclusion" will be completed, it will relate to the period of fifteen days preceding the diagnosis. From protocol v3.0: After performing a RT-PCR or an antigenic test for COVID diagnosis, the healthcare workers will complete a unique self-questionnaire about individual and contextual risks factors during the 15 days preceding the test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults healthcare workers, who are not opposed to participating in research.
Key inclusion criteria (5 listed)
- Hospital staff working in any of the 5 hospitals participating in the study,
- Of legal age,
- With or without a previous diagnosis of COVID-19 infection,
- Patient with a SARS-CoV-2 screening by RT-PCR or antigenic test (from version 3.0 of the protocol)
- Not opposed to participating in the research
Key exclusion criteria (3 listed)
- Unable or unwilling to complete the non-opposition
- Unable or unwilling to complete an online self-questionnaire (eCRF)
- Opposition to participate in research
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 |
|---|---|---|
| CohortNone. Only implementation of a cohort with data collection via individual self-questionnaires and administrative services for contextual data. | Other | Healthcare workers |
Primary outcome
SARS-COV-2 infection
Time frame: Up to 3 months
The primary endpoint will be the occurrence of confirmed (RT-PCR or antigenic test or work stopping) SARS-CoV-2 infection.
2 secondary outcomes
SARS-COV-2 incidence regarding hospitals, assigned services and profession
Time frame: Up to 3 months maximum
Individual and contextual risks factors
Time frame: Up to 3 months maximum
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 7 Feb 2022.
- Derived from this study: PubMed 36769854Bastuji-Garin S, Brouard L, Bourgeon-Ghittori I, Zebachi S, Boutin E, Hemery F, Fourreau F, Oubaya N, De Roux Q, Mongardon N, Fourati S, Decousser JW. The Relative Contributions of Occupational and Community Risk Factors for COVID-19 among Hospital Workers: The HOP-COVID Cohort Study. J Clin Med. 2023 Feb 2;12(3):1208. doi: 10.3390/jcm12031208.
- Individual participant dataSharing planned: No. Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.
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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.
Sylvie BASTUJI-GARIN, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris 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 7 Feb 2022. 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 infection (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386759, which also lists 1 linked publication.
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 7 Feb 2022.