COVID-19 Infection in Healthcare Workers

COVID-19 Clinical Trial

— HOP-COVID  

Official title:

COVID-19 Infection in Healthcare Workers: a Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386759
• Other study ID #: APHP200483
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: July 26, 2021

Study information

• Verified date: August 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1858
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

• 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

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

Related Conditions & MeSH terms

• COVID-19
• Infections

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 months
Secondary	SARS-COV-2 incidence regarding hospitals, assigned services and profession	Information collected by a self questionnaire and service datas	Up to 3 months maximum
Secondary	Individual and contextual risks factors	Risks factor are collected by a self questionnaire and service datas	Up to 3 months maximum