NCT04516928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

4 days

First QC Date

August 14, 2020

Last Update Submit

March 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants)

    Day 0

  • Correlation coefficient between medical risk factors and a positive serology

    Day 0

  • Correlation coefficient between epidemiological risk factors and a positive serology

    Day 0

  • Correlation coefficient between social risk factors and a positive serology

    Day 0

Interventions

The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed of personnel of the Military Health Schools of Lyon-Bron (students, teachers, supervisors).

You may qualify if:

  • 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

You may not qualify if:

  • under 18
  • contraindication to blood sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antenne Médicale des Ecoles Militaires de Santé de Lyon-Bron (EMSLB)

Bron, 69675, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 18, 2020

Study Start

September 21, 2020

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations