NCT04481529

Brief Summary

Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers. This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate. Since june 2020, all staff in French health establishments could benefit a serological test. Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.

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
1,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

July 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 29, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 13, 2021

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

July 20, 2020

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with a COVID-19 seroconversion

    Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver).

    through study completion, an average of 5 month

Interventions

Completion of a short questionnaire noting the result of the serology and looking for elements in favor of exposure to the virus, whether professional or extra-professional.

Eligibility Criteria

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

Hospital staff

You may qualify if:

  • Hospital staff from Argenteuil, Belfort, Dijon and Limoges hospitals.
  • Age ≥ 18 years old
  • Participation agreement

You may not qualify if:

  • Protected persons
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CH Argenteuil - Service de Réanimation

Argenteuil, 95107, France

Location

Ch Belfort

Belfort, 90000, France

Location

CHU Dijon - Serve de Réanimation

Dijon, 21079, France

Location

CHU de Limoges

Limoges, France

Location

MeSH Terms

Conditions

Virus Diseases

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 22, 2020

Study Start

July 29, 2020

Primary Completion

December 15, 2020

Study Completion

January 15, 2021

Last Updated

January 13, 2021

Record last verified: 2020-11

Locations