SARS-CoV InfectionSeroCovEmsNCT04516928
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
An observational study of SARS-CoV Infection and Covid19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Covid19
- What is being tested?
- Anti-SARS-CoV2 Serology and Questionnaire
- How many people
- 392 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2020to 25 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be composed of personnel of the Military Health Schools of Lyon-Bron (students, teachers, supervisors).
Who may be able to join
- 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
Who cannot join
- under 18
- contraindication to blood sampling
Trial locations and contacts
1 site in 1 country.
France1 site
Antenne Médicale des Ecoles Militaires de Santé de Lyon-Bron (EMSLB)
Bron, 69675
About this study
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.
Read more
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.
- Conditions
- SARS-CoV Infection, Covid19
- Being tested
- Anti-SARS-CoV2 Serology, Questionnaire
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-SARS-CoV2 SerologyDiagnostic test
The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.
QuestionnaireOther
A questionnaire on socio-demographical status, health status and lifestyle habits during the pandemic will be filled by the participants at Day 0.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start21 Sep 2020
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516928
- Sponsor's protocol ID
- 2020-COVID19-29
- Other IDs
- 2020-A02125-34
- Acronym
- SeroCovEms
- Status last verified
- Mar 2021
- First submitted
- 14 Aug 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel
- ClinicalTrials.gov ID
- NCT04516928
- Acronym / sponsor ID
- SeroCovEms / 2020-COVID19-29
- Conditions
- SARS-CoV Infection, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of personnel of the Military Health Schools of Lyon-Bron (students, teachers, supervisors).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- under 18
- contraindication to blood sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-SARS-CoV2 SerologyThe anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0. | Diagnostic test | – |
| QuestionnaireA questionnaire on socio-demographical status, health status and lifestyle habits during the pandemic will be filled by the participants at Day 0. | Other | – |
Primary outcome
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.
4 secondary outcomes
Proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants)
Time frame: Day 0
Correlation coefficient between medical risk factors and a positive serology
Time frame: Day 0
Correlation coefficient between epidemiological risk factors and a positive serology
Time frame: Day 0
Correlation coefficient between social risk factors and a positive serology
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for SARS-CoV Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
SARS-CoV Infection
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Covid19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of anti-SARS-CoV2 seropositive participants (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.