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

NCT04404270 | Completed

• 2 other identifiers: 2020-COVID19-222020-A01368-31
• Study Type: observational
• Target: 1,146
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of asymptomatic anti-SARS-CoV2 seropositive participants

  Day 0

• Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)

  Day 0

• Proportion of serum neutralization positive

  Day 0

• Change of antibody level over time

  3 months and 9 months after Day 0

Interventions

Anti-SARS-CoV2 Serology DIAGNOSTIC_TEST

The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.

Questionnaire BEHAVIORAL

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 neutralization DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

24e antenne médicale de Creil

Creil, 60314, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 27, 2020
• Study Start: May 26, 2020
• Primary Completion: March 13, 2021
• Study Completion: March 13, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

FR (1)