Clinical trial NCT04387838: Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff
Official title: Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 845
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of army training hospital staff who have not already been confirmed Covid-19 positive and who are not taking any treatment relative with Covid-19.

Brief summary: Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.


Eligibility criteria: Inclusion Criteria:

* Army Training Hospital staff

Exclusion Criteria:

* Individuals who have already been confirmed Covid-19 positive
* Individuals taking preventive anti-Covid-19 therapy or considering participating in anti-Covid-19 therapy study
* Individuals on hydroxychloroquine
* Pregnant or breastfeeding women
* Non-permanent staff during the study period
* Individuals identified for a detachment outside the metropole during the study period

Primary outcomes:
measure: Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.
timeFrame: From Day 0 to Day 60
measure: Anti-SARS-Cov2 seroconversion between Day 0 and Day 30.
timeFrame: From Day 0 to Day 30
measure: Anti-SARS-Cov2 seroconversion between Day 30 and Day 60.
timeFrame: From Day 30 to Day 60
Secondary outcomes:
measure: Anti-SARS-Cov2 seroprevalence at Day 0.
timeFrame: Day 0
measure: Correlation between seroconversion and socio-demographic factors - sex
timeFrame: Day 60
measure: Correlation between seroconversion and socio-demographic factors - age
timeFrame: Day 60
measure: Correlation between seroconversion and professional factors - job type
timeFrame: Day 60
measure: Correlation between seroconversion and professional factors - personal protective equipment type
timeFrame: Day 60
measure: Correlation between seroconversion and non-professional factors - contact with infected individuals
timeFrame: Day 60
measure: Correlation between seroconversion and non-professional factors - wearing of professional equipment
timeFrame: Day 60
measure: Correlation between seroconversion and non-professional factors - respect of barrier gestures
timeFrame: Day 60
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital d'Instuction des Armées Sainte-Anne
city: Villenave-d'Ornon
country: France
facility: Hôpital d'Instruction des Armées Robert Picqué
Study officials:
References: