NCT04371692

Brief Summary

The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2020

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

24 days

First QC Date

April 28, 2020

Last Update Submit

April 22, 2021

Conditions

Keywords

PrevalenceHealth Care Workersoccupational exposureenvironmental exposureserological testingRT-PCR

Outcome Measures

Primary Outcomes (1)

  • the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection

    at 2 months

Secondary Outcomes (5)

  • the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection

    once week during 2 months

  • Occupational exposures associated with the SARS-Cov2 infection

    once week during 2 months

  • Environmental exposures associated with the SARS-Cov2 infection

    once week during 2 months

  • immunologic status of health Care Worker

    once week during 2 months

  • inflammatory biomarkers status of Health Care Worker

    once week during 2 months

Study Arms (3)

High-risk

staff working in a unit specifically for patients infected or suspected of being infected with SARS-Cov2

Other: self-administered questionnaireDiagnostic Test: SARS-Cov2 testing

Medium- risk

staff working in a unit that can accommodate patients infected or suspected of being infected with SARS-Cov2, i.e., all care services that do not fall into the high-risk group.

Other: self-administered questionnaireDiagnostic Test: SARS-Cov2 testing

Low-risk

off-patient staff

Other: self-administered questionnaireDiagnostic Test: SARS-Cov2 testing

Interventions

Every weeks during 2 months, 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
High-riskLow-riskMedium- risk
SARS-Cov2 testingDIAGNOSTIC_TEST

Every weeks during 2 month, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure

High-riskLow-riskMedium- risk

Eligibility Criteria

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

Health Care workers with or without symptoms suggestive of a COVID-19 infection

You may qualify if:

  • \- Health Care workers with or without symptoms suggestive of a COVID-19 infection

You may not qualify if:

  • HCW working off-site at the CHU de Lille
  • HCW on sick leave.
  • HCW outside the Lille University Hospital temporarily coming as reinforcements in the context of the epidemic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

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

Study Design

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

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 1, 2020

Study Start

June 15, 2020

Primary Completion

July 9, 2020

Study Completion

July 9, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations