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

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 Overview

• Status: Completed
• Conditions: Sars-CoV2
• Intervention / Treatment: Diagnostic test: Anti-SARS-CoV2 Serology; Behavioral: Questionnaire; Diagnostic test: Anti-SARS-CoV2 serological controls and serum neutralization

• Study Type: Observational
• Enrollment (Actual): 1146

Contacts and Locations

Study Locations

• France
  • Creil, France, 60314
    • 24e antenne médicale de Creil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): March 13, 2021
• Study Completion (Actual): March 13, 2021

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-COVID19-22; 2020-A01368-31 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No