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COVID-19 Infection in Healthcare Workers (HOP-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386759
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease Intervention/treatment
COVID-19 Other: Cohort

Detailed Description:

Details for "Study design" section

Time perspective : Retrospective and prospective cohort study.

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.

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: COVID-19 Infection in Healthcare Workers: a Cohort Study
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthcare workers

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.

Other: Cohort
None. Only implementation of a cohort with data collection via individual self-questionnaires and administrative services for contextual data.




Primary Outcome Measures :
  1. SARS-COV-2 infection [ Time Frame: At inclusion ]
    The primary endpoint will be the occurrence of confirmed (RT-PCR or work stopping) SARS-CoV-2 infection.

  2. SARS-COV-2 infection [ Time Frame: Up to 3 months ]
    The primary endpoint will be the occurrence of confirmed (RT-PCR or work stopping) SARS-CoV-2 infection.


Secondary Outcome Measures :
  1. Individual factors [ Time Frame: At inclusion ]
    Individual factors collected by a self-questionnaire

  2. Individual factors [ Time Frame: Up to 3 months ]
    Individual factors collected by a self-questionnaire

  3. Hospital ward level [ Time Frame: Up to 3 months ]
    Weekly consumption of masks and hydroalcoholic solution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults healthcare workers, who are not opposed to participating in research.
Criteria

Inclusion Criteria:

  • 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,
  • Not opposed to participating in the research

Exclusion Criteria:

  • Unable or unwilling to complete the non-opposition
  • Unable or unwilling to complete an online self-questionnaire (eCRF)
  • Opposition to participate in research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386759


Contacts
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Contact: Sylvie BASTUJI-GARIN, MD, PhD +33 6 74 49 71 57 sylvie.bastuji-garin@aphp.fr

Locations
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France
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, France, 94 010
Contact: Sylvie BASTUJI-GARIN, MD, PhD    +33 6 74 49 71 57    sylvie.bastuji-garin@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Sylvie BASTUJI-GARIN, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04386759    
Other Study ID Numbers: APHP200483
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19
Healthcare workers
Incidence
Risk factors
Nosocomial infection
Additional relevant MeSH terms:
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Infection