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Clinical Trials/NCT04387838
NCT04387838
Completed
Not Applicable

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

Direction Centrale du Service de Santé des Armées2 sites in 1 country845 target enrollmentMay 14, 2020
ConditionsSars-CoV2

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sars-CoV2
Sponsor
Direction Centrale du Service de Santé des Armées
Enrollment
845
Locations
2
Primary Endpoint
Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2020
End Date
August 15, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Direction Centrale du Service de Santé des Armées
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.

Time Frame: From Day 0 to Day 60

Change 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.

Time Frame: From Day 0 to Day 30

Change 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.

Time Frame: From Day 30 to Day 60

Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample.

Secondary Outcomes

  • Anti-SARS-Cov2 seroprevalence at Day 0.(Day 0)
  • Correlation between seroconversion and socio-demographic factors - sex(Day 60)
  • Correlation between seroconversion and socio-demographic factors - age(Day 60)
  • Correlation between seroconversion and professional factors - job type(Day 60)
  • Correlation between seroconversion and professional factors - personal protective equipment type(Day 60)
  • Correlation between seroconversion and non-professional factors - contact with infected individuals(Day 60)
  • Correlation between seroconversion and non-professional factors - wearing of professional equipment(Day 60)
  • Correlation between seroconversion and non-professional factors - respect of barrier gestures(Day 60)

Study Sites (2)

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