- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516928
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel (SeroCovEms)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bron, France, 69675
- Antenne Médicale des Ecoles Militaires de Santé de Lyon-Bron (EMSLB)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of anti-SARS-CoV2 seropositive participants
Time Frame: 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.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants)
Time Frame: 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.
|
Day 0
|
Correlation coefficient between medical risk factors and a positive serology
Time Frame: Day 0
|
Correlation coefficient between medical risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
|
Day 0
|
Correlation coefficient between epidemiological risk factors and a positive serology
Time Frame: Day 0
|
Correlation coefficient between epidemiological risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
|
Day 0
|
Correlation coefficient between social risk factors and a positive serology
Time Frame: Day 0
|
Correlation coefficient between social risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
|
Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-COVID19-29
- 2020-A02125-34 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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