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Completed

NCT Number: NCT04404270

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

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.

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Key information

Conditions

Sars-CoV2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

24e antenne médicale de Creil

Creil, 60314, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of asymptomatic anti-SARS-CoV2 seropositive participants

    Time frame: 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.

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

    Time frame: 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.

  3. Proportion of serum neutralization positive

    Time frame: Day 0

    Among anti-SARS-CoV2 seropositive participants, the percentage of participants with a positive response to serum neutralization will be determined.

  4. Change of antibody level over time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: EpiCovCreil

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 27, 2020
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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