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

Completed

• Conditions: Sars-CoV2

• Registration Number: NCT04387838
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study Start: 2020-05-14
• Study First Posted: 2020-05-14
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 845

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hôpital d'Instuction des Armées Sainte-Anne; 🇫🇷 Toulon, France

Hôpital d'Instruction des Armées Robert Picqué; 🇫🇷 Villenave-d'Ornon, France