NCT04362267

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 23, 2020

Last Update Submit

August 4, 2020

Conditions

Keywords

IncidenceHealth Care Workersoccupational exposureenvironmental exposureserological testingRT-PCR

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Occupational exposures associated with the SARS-Cov2 infection

    once every 14 days for an average of 14 weeks

  • Environmental exposures associated with the SARS-Cov2 infection

    once every 14 days for an average of 14 weeks

Interventions

Every14 days, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure

Also known as: a specifically designed self-administered questionnaire
SARS-Cov2 testingDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health Care workers exposed to covid occupational exposure

You may qualify if:

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

You may not qualify if:

  • Heath Care Worker with SARS-Cov2 infection ( RT-PCR +) or SARS-Cov2 immunity in serological testing
  • HCW off work
  • Subjects on leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, 59037, France

RECRUITING

MeSH Terms

Interventions

COVID-19 Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Annie SOBASZEK, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie SOBASZEK, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 24, 2020

Study Start

June 15, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

August 6, 2020

Record last verified: 2020-04

Locations