Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)

Sars-CoV2 Clinical Trial

— EpiCovCreil  

Official title:

Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404270
• Other study ID #: 2020-COVID19-22
• Secondary ID: 2020-A01368-31
• Status: Completed
• Start date: May 26, 2020
• Est. completion date: March 13, 2021

Study information

• Verified date: July 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1146
• Est. completion date: March 13, 2021
• Est. primary completion date: March 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Contraindication to blood sampling
• Pregnant, parturient, breastfeeding woman

Related Conditions & MeSH terms

• Sars-CoV2

Intervention

Diagnostic Test:
• Anti-SARS-CoV2 Serology
The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.

Behavioral:
• Questionnaire
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.

Diagnostic Test:
• Anti-SARS-CoV2 serological controls and serum neutralization
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.

Locations

Country	Name	City	State
France	24e antenne médicale de Creil	Creil

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	3 months and 9 months after Day 0