COVID-19 Infection in Healthcare Workers

NCT04386759 | Completed

• 1 other identifier: APHP200483
• Study Type: observational
• Target: 1,858
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Healthcare workers; Incidence; Risk factors; Nosocomial infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SARS-COV-2 incidence regarding hospitals, assigned services and profession

  Up to 3 months maximum

• Individual and contextual risks factors

  Up to 3 months maximum

Study Arms (1)

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.

Other: Cohort

Interventions

Cohort OTHER

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

Healthcare workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults healthcare workers, who are not opposed to participating in research.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, 94 010, France

Location

Related Publications (1)

• 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.

  PMID: 36769854 DERIVED

MeSH Terms

Conditions

COVID-19; Cross Infection

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sylvie BASTUJI-GARIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 13, 2020
• Study Start: May 18, 2020
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: February 7, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)