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Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04387838
Acronym
SEROSARSCOV
Enrollment
845
Registered
2020-05-14
Start date
2020-05-14
Completion date
2020-08-15
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sars-CoV2

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.

Interventions

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.

OTHERQuestionnaire

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

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.From Day 0 to Day 60Change of Anti-SARS-Cov2 serological status between Day 0 and Day 60, measured in blood sample.
Anti-SARS-Cov2 seroconversion between Day 0 and Day 30.From Day 0 to Day 30Change of Anti-SARS-Cov2 serological status between Day 0 and Day 30, measured in blood sample.
Anti-SARS-Cov2 seroconversion between Day 30 and Day 60.From Day 30 to Day 60Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample.

Secondary

MeasureTime frameDescription
Correlation between seroconversion and professional factors - job typeDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and job type (nurse, physician, etc.)
Correlation between seroconversion and professional factors - personal protective equipment typeDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and personal protective equipment type
Anti-SARS-Cov2 seroprevalence at Day 0.Day 0Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.
Correlation between seroconversion and non-professional factors - wearing of professional equipmentDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and wearing of professional equipment
Correlation between seroconversion and non-professional factors - respect of barrier gesturesDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and respect of barrier gestures
Correlation between seroconversion and non-professional factors - contact with infected individualsDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and contact with infected individuals
Correlation between seroconversion and socio-demographic factors - sexDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and sex
Correlation between seroconversion and socio-demographic factors - ageDay 60Correlation between seroconversion (measured in blood sample) at Day 60 and age

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026