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

Completed

• Conditions: Sars-CoV2

• Registration Number: NCT04404270
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study Start: 2020-05-26
• Study First Posted: 2020-05-27
• Primary Completion: 2021-03-13
• Study Completion: 2021-03-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1146

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion anti-SARS-CoV2 seropositive	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

Secondary Outcome Measures

Name	Time	Method
Proportion of asymptomatic anti-SARS-CoV2 seropositive participants	Day 0	Among anti-SARS-CoV2 seropositive participants, the percentage of asymptomatic participants will be determined. COVID-19 symptoms will be measured using a questionnaire.
Change of antibody level over time	3 months and 9 months after Day 0	The evolution of the antibody level over time will be determined using repeated serodiagnoses at 3 and 9 months.
Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)	Day 0	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.
Proportion of serum neutralization positive	Day 0	Among anti-SARS-CoV2 seropositive participants, the percentage of participants with a positive response to serum neutralization will be determined.

Trial Locations

Locations (1)

24e antenne médicale de Creil; 🇫🇷 Creil, France