COVID-19 Infection in Healthcare Workers (HOP-COVID)
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|ClinicalTrials.gov Identifier: NCT04386759|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|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|
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.
None. Only implementation of a cohort with data collection via individual self-questionnaires and administrative services for contextual data.
- 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.
- 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.
- Individual factors [ Time Frame: At inclusion ]Individual factors collected by a self-questionnaire
- Individual factors [ Time Frame: Up to 3 months ]Individual factors collected by a self-questionnaire
- Hospital ward level [ Time Frame: Up to 3 months ]Weekly consumption of masks and hydroalcoholic solution
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
|Contact: Sylvie BASTUJI-GARIN, MD, PhD||+33 6 74 49 71 email@example.com|
|Assistance Publique Hôpitaux de Paris - CHU Henri Mondor|
|Créteil, France, 94 010|
|Contact: Sylvie BASTUJI-GARIN, MD, PhD +33 6 74 49 71 57 firstname.lastname@example.org|
|Study Director:||Sylvie BASTUJI-GARIN, MD, PhD||Assistance Publique - Hôpitaux de Paris|