NCT04353323

Brief Summary

According to recent publications, the percentage of caregivers infected with COVID 19 is evaluated between 10 and 30% . This great variability is due, on the one hand to the intensity of the influx of covid plus patients and, on the other hand, to the disparity in the preparation of caregivers in the face of this emergency. Indeed, we can understand that the strict application of hygiene rules can be faulted in the face of the volume of patients, the lack of protective equipment and the lack of specific training for caregivers in this area. As a result, within healthcare teams, there are many questions that generate anxiety: will I be able to provide care properly while protecting myself from the risk of contamination? This anxiety is also present and sometimes manifests itself aggressively in the entourage or in the vicinity of caregivers, due to lack of scientific data adapted to the local ecology of the crisis. Thus, the aim of this study is to show that the risk for caregivers of being contaminated by COVID in an area dedicated to COVID positive patients is no higher than being a caregiver in a non-COVID area that he either in the adult or pediatric sector.

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
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

May 11, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 15, 2020

Last Update Submit

May 8, 2020

Conditions

Infection, COVID-19

Outcome Measures

Primary Outcomes (3)

  • Seroconversion

    Participants seroconverion will be assessed by analysing IgG When the seroconverion is confirmed (whenever it occurs), the participant ends his partipation.

    Day1

  • Seroconversion

    Participants seroconverion will be assessed by analysing IgG When the seroconverion is confirmed (whenever it occurs), the participant ends his partipation.

    Day 15

  • Seroconversion

    Participants seroconverion will be assessed by analysing IgG When the seroconverion is confirmed (whenever it occurs), the participant ends his partipation.

    Day 30

Study Arms (2)

Covid area

Other: Blood sampling

Non-Covid area

Other: Blood sampling

Interventions

Blood samplingOTHER

3 blood samples (D0, D15 and D30) will be taken from each participant

Covid areaNon-Covid area

Eligibility Criteria

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

Caregivers staff assigned to a non-intensive care COVID service * Or caregiversg staff assigned to a non-COVID adult service * Or caregivers staff assigned to a non-COVID pediatric service

You may qualify if:

  • caregivers staff assigned to a non-intensive care COVID service
  • or caregivers staff assigned to a non-COVID adult service
  • or caregivers staff assigned to a non-COVID pediatric service
  • Age \> = 18 years old
  • With health insurance
  • Express consent

You may not qualify if:

  • Protected persons
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges

Limoges, France

Location

MeSH Terms

Conditions

InfectionsCOVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Laurent FOURCADE, MD

CONTACT

0555058070laurent.fourcade@unilim.fr

Study Design

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

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

May 25, 2020

Primary Completion

June 25, 2020

Study Completion

December 25, 2020

Last Updated

May 11, 2020

Record last verified: 2020-04

Locations

FR(1)