Clinical trial NCT04386759: COVID-19 Infection in Healthcare Workers
Official title: COVID-19 Infection in Healthcare Workers: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Healthcare workers
Incidence
Risk factors
Nosocomial infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 1858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults healthcare workers, who are not opposed to participating in research.

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.

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.

Eligibility 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,
* 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

Primary outcomes:
measure: SARS-COV-2 infection
timeFrame: Up to 3 months
Secondary outcomes:
measure: SARS-COV-2 incidence regarding hospitals, assigned services and profession
timeFrame: Up to 3 months maximum
measure: Individual and contextual risks factors
timeFrame: Up to 3 months maximum
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sylvie BASTUJI-GARIN, MD, PhD
role: STUDY_DIRECTOR
References: