Sars-CoV2EpiCovCreilNCT04404270
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)
An observational study of Sars-CoV2, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Anti-SARS-CoV2 Serology and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,146 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2020to 13 Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The eligible population is composed of all civilian and military personnel working on the Creil Air Force Base (BA110) or having worked on BA110 as a permanent personnel since February 1st 2020, including the people working in satellite units such as the "Groupement de soutien de base de Défense" de Creil ("Creil Defence Base Support Group") or the 3/60 Esterel squadron.
Who may be able to join
- Active military or civilian defence personnel working on the Creil Air Force Base (BA110) during the period of interest (from February 1st 2020 to the end of the study)
Who cannot join
- Contraindication to blood sampling
- Pregnant, parturient, breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible.
The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.
- Conditions
- Sars-CoV2
- Being tested
- Anti-SARS-CoV2 Serology, Questionnaire, Anti-SARS-CoV2 serological controls and serum neutralization
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.
QuestionnaireBehavioural
Epidemiological data will be collected in a questionnaire that will be filled by participants at Day 0 (Visit 1), after 3 months (Visit 2) and after 9 months (Visit 3).
The questionnaire includes:
- medical data (height, weight, smoking, history of intense stress);
- socio-demographic data (age, gender, civil/military status, function/occupation, rank category, army, family status/home composition, housing conditions, etc.);
- clinical data : history of symptoms suggestive of COVID-19 in the last 3 months, current symptoms suggestive of COVID-19;
- use of care, hospitalization, work stoppage in the last 3 months;
- contact with people who are symptomatic or proven COVID-19.
Anti-SARS-CoV2 serological controls and serum neutralizationDiagnostic test
Serological controls and a serum neutralization test will be performed on blood samples collected 3 months (Visit 2) and 9 months (Visit 3) after Day 0, respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion anti-SARS-CoV2 seropositive
The percentage of the study population with positive serological status 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 anti-SARS-CoV2 seropositive participants
Among anti-SARS-CoV2 seropositive participants, the percentage of asymptomatic participants will be determined. COVID-19 symptoms will be measured using a questionnaire.
Measured: Day 0
Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)
The serological results obtained using the reference ELISA test results (detecting the presence of IgG and IgM antobodies) and using a second ELISA test detecting the presence of antibodies specifically directed against the Receptor Binding Domain and the Spike protein trimer of SARS-CoV2 virus will be compared.
Measured: Day 0
Proportion of serum neutralization positive
Among anti-SARS-CoV2 seropositive participants, the percentage of participants with a positive response to serum neutralization will be determined.
Measured: Day 0
Change of antibody level over time
The evolution of the antibody level over time will be determined using repeated serodiagnoses at 3 and 9 months.
Measured: 3 months and 9 months after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start26 May 2020
- Primary completion13 Mar 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies 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
- 1,146 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
- NCT04404270
- Sponsor's protocol ID
- 2020-COVID19-22
- Other IDs
- 2020-A01368-31
- Acronym
- EpiCovCreil
- Status last verified
- Jul 2021
- First submitted
- 25 May 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)
- ClinicalTrials.gov ID
- NCT04404270
- Acronym / sponsor ID
- EpiCovCreil / 2020-COVID19-22
- Conditions
- Sars-CoV2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 27 May 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.
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible.
The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible population is composed of all civilian and military personnel working on the Creil Air Force Base (BA110) or having worked on BA110 as a permanent personnel since February 1st 2020, including the people working in satellite units such as the "Groupement de soutien de base de Défense" de Creil ("Creil Defence Base Support Group") or the 3/60 Esterel squadron.
Key inclusion criteria (1 listed)
- Active military or civilian defence personnel working on the Creil Air Force Base (BA110) during the period of interest (from February 1st 2020 to the end of the study)
Key exclusion criteria (2 listed)
- Contraindication to blood sampling
- Pregnant, parturient, breastfeeding woman
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 | – |
| QuestionnaireEpidemiological data will be collected in a questionnaire that will be filled by participants at Day 0 (Visit 1), after 3 months (Visit 2) and after 9 months (Visit 3). The questionnaire includes: * medical data (height, weight, smoking, history of intense stress); * socio-demographic data (age, gender, civil/military status, function/occupation, rank category, army, family status/home composition, housing conditions, etc.); * clinical data : history of symptoms suggestive of COVID-19 in the last 3 months, current symptoms suggestive of COVID-19; * use of care, hospitalization, work stoppage in the last 3 months; * contact with people who are symptomatic or proven COVID-19. | Behavioural | – |
| Anti-SARS-CoV2 serological controls and serum neutralizationSerological controls and a serum neutralization test will be performed on blood samples collected 3 months (Visit 2) and 9 months (Visit 3) after Day 0, respectively. | Diagnostic test | – |
Primary outcome
Proportion anti-SARS-CoV2 seropositive
Time frame: Day 0
The percentage of the study population with positive serological status 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 anti-SARS-CoV2 seropositive participants
Time frame: Day 0
Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)
Time frame: Day 0
Proportion of serum neutralization positive
Time frame: Day 0
Change of antibody level over time
Time frame: 3 months and 9 months after 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 7 Jul 2021.
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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-CoV2, 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 1 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 7 Jul 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 anti-SARS-CoV2 seropositive (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 7 Jul 2021.