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

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Completed
CT.gov ID
NCT04516928
Collaborator
(none)
392
1
4
2982.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Anti-SARS-CoV2 Serology
  • Other: Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
392 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
Actual Study Start Date :
Sep 21, 2020
Actual Primary Completion Date :
Sep 25, 2020
Actual Study Completion Date :
Sep 25, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antenne Médicale des Ecoles Militaires de Santé de Lyon-Bron (EMSLB) Bron France 69675

Sponsors and Collaborators

  • Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT04516928
Other Study ID Numbers:
  • 2020-COVID19-29
  • 2020-A02125-34
First Posted:
Aug 18, 2020
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021