Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel

Completed

• Conditions: SARS-CoV Infection; Covid19

• Registration Number: NCT04516928
• 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 is by droplet route, with an 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.

During the period of containment, the majority of students from the Lyon-Bron Military Medical Schools were sent as reinforcement in Army Training Hospitals and in the Military Reanimation Unit (Mulhouse). Some students developed symptomatic forms of SARS-Cov-2 infection, documented by positive PCR, during Operation Resilience or on their return from the mission.

The Lyon-Bron Military Medical Schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-18
• Study Start: 2020-09-21
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

• at least 18 years of age
• personnel of the Military Health Schools of Lyon-Bron
• working at the Military Health Schools of Lyon-Bron during the COVID-19 crisis

Exclusion Criteria

• under 18
• contraindication to blood sampling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of anti-SARS-CoV2 seropositive participants	Day 0	The proportion of anti-SARS-CoV2 seropositive participants will be determined. ELISA serology test will be used to detect anti-SARS-CoV2 antibodies (IgG and IgM) at Day 0.

Secondary Outcome Measures

Name	Time	Method
Proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants)	Day 0	The proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants) will be determined. COVID-19 symptoms will be measured using a questionnaire.
Correlation coefficient between social risk factors and a positive serology	Day 0	Correlation coefficient between social risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
Correlation coefficient between medical risk factors and a positive serology	Day 0	Correlation coefficient between medical risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
Correlation coefficient between epidemiological risk factors and a positive serology	Day 0	Correlation coefficient between epidemiological risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.

Trial Locations

Locations (1)

Antenne Médicale des Ecoles Militaires de Santé de Lyon-Bron (EMSLB); 🇫🇷 Bron, France