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

Covid19 Clinical Trial

— SeroCovEms  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516928
• Other study ID #: 2020-COVID19-29
• Secondary ID: 2020-A02125-34
• Status: Completed
• Start date: September 21, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: March 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Anti-SARS-CoV2 Serology
The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.

Other:
• Questionnaire
A questionnaire on socio-demographical status, health status and lifestyle habits during the pandemic will be filled by the participants at Day 0.

Locations

Country	Name	City	State
France	Antenne Médicale des Ecoles Militaires de Santé de Lyon-Bron (EMSLB)	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

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