Clinical trial NCT04376944: Barrier Measures to Limit Covid-19.Nosocomial Transmission: a Cross-sectional Evaluation
Official title: Evaluating Effectiveness of Barrier Measures to Limit Nosocomial Transmission: Covid-19 Prevalence Survey Among Caregivers With Various Exposures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caregivers
COVID-19
Keywords: barrier measures
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: carers of the UH Montpellier

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

- refusal to participate

Primary outcomes:
measure: Proportion of caregivers and agents with a positive serodiagnosis
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of caregivers and agents with a positive RT-PCR
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marie Bistoquet, MD
role: PRINCIPAL_INVESTIGATOR
References: