An observational study in Sars-CoV2, sponsored by Direction Centrale du Service de Santé des Armées. Completed at 2 sites in France. Open to participants aged 18 Years to 62 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Direction Centrale du Service de Santé des Armées · Observational
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.
Direction Centrale du Service de Santé des Armées is the lead sponsor of 93 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
At Day 0, a blood sample is collected by venipuncture and a questionnaire is being filled. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France. For individuals who are anti-SARS-CoV2 seronegative, the same intervention is made at Day 30 and D60. For the individuals who are anti-SARS-CoV2 seropositive, the study follow-up is stopped.
Diagnostic Test: Anti-SARS-CoV2 Serology · Other: Questionnaire
A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.
Data concerning personal exposure factors are collected in a questionnaire: * Socio-demographic factors: sex, age * Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital * Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures
Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.
Change of Anti-SARS-Cov2 serological status between Day 0 and Day 60, measured in blood sample.
Time frame: From Day 0 to Day 60
Anti-SARS-Cov2 seroconversion between Day 0 and Day 30.
Change of Anti-SARS-Cov2 serological status between Day 0 and Day 30, measured in blood sample.
Time frame: From Day 0 to Day 30
Anti-SARS-Cov2 seroconversion between Day 30 and Day 60.
Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample.
Time frame: From Day 30 to Day 60
Anti-SARS-Cov2 seroprevalence at Day 0.
Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.
Time frame: Day 0
Correlation between seroconversion and socio-demographic factors - sex
Correlation between seroconversion (measured in blood sample) at Day 60 and sex
Time frame: Day 60
Correlation between seroconversion and socio-demographic factors - age
Correlation between seroconversion (measured in blood sample) at Day 60 and age
Time frame: Day 60
Correlation between seroconversion and professional factors - job type
Correlation between seroconversion (measured in blood sample) at Day 60 and job type (nurse, physician, etc.)
Time frame: Day 60
Correlation between seroconversion and professional factors - personal protective equipment type
Correlation between seroconversion (measured in blood sample) at Day 60 and personal protective equipment type
Time frame: Day 60
Correlation between seroconversion and non-professional factors - contact with infected individuals
Correlation between seroconversion (measured in blood sample) at Day 60 and contact with infected individuals
Time frame: Day 60
Correlation between seroconversion and non-professional factors - wearing of professional equipment
Correlation between seroconversion (measured in blood sample) at Day 60 and wearing of professional equipment
Time frame: Day 60
Correlation between seroconversion and non-professional factors - respect of barrier gestures
Correlation between seroconversion (measured in blood sample) at Day 60 and respect of barrier gestures
Time frame: Day 60
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Direction Centrale du Service de Santé des Armées