NCT04376944

Brief Summary

Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs. In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits. In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients. Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 4, 2020

Last Update Submit

May 5, 2020

Conditions

Keywords

barrier measures

Outcome Measures

Primary Outcomes (1)

  • Proportion of caregivers and agents with a positive serodiagnosis

    Proportion of caregivers and agents with a positive serodiagnosis in COVID units versus non-COVID units

    1 day

Secondary Outcomes (1)

  • Proportion of caregivers and agents with a positive RT-PCR

    1 day

Study Arms (2)

Exposed group

Caregivers and agents working directly in COVID units compared to those living.

Other: Survey

Control group

caregivers anf agents working in services excluding the management of patients screened positive for Covid-19 infection

Other: Survey

Interventions

SurveyOTHER

questionnaire on their symptoms and their exposures

Control groupExposed group

Eligibility Criteria

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

carers of the UH Montpellier

You may qualify if:

  • exposed group: exposed caregivers and agents who worked in COVID units (medicine, resuscitation, screening) until their date of collection. An exposed agent or caregiver is defined by the entrance of rooms with a COVID-19 infection during their professional activity.
  • low or unexposed group: caregivers or agents who have worked in non-COVID units in a non-COVID hospital

You may not qualify if:

  • \- refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

NC

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marie Bistoquet, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain MAKINSON, MCU-PH

CONTACT

Marie Bistoquet, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 6, 2020

Study Start

April 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations