Longitudinal Study of Covid-19 Infection Among HCW in a French University Hospital

Sars-CoV2 Clinical Trial

— PRECOVIA  

Official title:

Incidence of SARS-Cov2 Infection Among HCW in Lille University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04362267
• Other study ID #: 2020_34
• Secondary ID: 2020-A00950-39
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Lille
• Contact: Annie SOBASZEK, MD,PhD
• Phone: 03.20.44.43.66
• Email: annie.sobaszek[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure.

The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Health Care workers with covid high exposure during the care activities

Exclusion Criteria:

• Heath Care Worker with SARS-Cov2 infection ( RT-PCR +) or SARS-Cov2 immunity in serological testing

• HCW off work

• Subjects on leave

Related Conditions & MeSH terms

• Infection
• Sars-CoV2

Intervention

Other:
• self-administered questionnaire
Every14 days, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure

Diagnostic Test:
• SARS-Cov2 testing
Every14 days, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Fondation Santé Roquette

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing		at 14 weeks
Secondary	the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing		once every 14 days for an average of 14 weeks
Secondary	Occupational exposures associated with the SARS-Cov2 infection		once every 14 days for an average of 14 weeks
Secondary	Environmental exposures associated with the SARS-Cov2 infection		once every 14 days for an average of 14 weeks