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Completed

NCT Number: NCT04387838

Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.

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Key information

Conditions

Sars-CoV2

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instuction des Armées Sainte-Anne, Toulon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Army Training Hospital staff

Exclusion criteria

  • Individuals who have already been confirmed Covid-19 positive
  • Individuals taking preventive anti-Covid-19 therapy or considering participating in anti-Covid-19 therapy study
  • Individuals on hydroxychloroquine
  • Pregnant or breastfeeding women
  • Non-permanent staff during the study period
  • Individuals identified for a detachment outside the metropole during the study period

Treatment and study plan

Anti-SARS-CoV2 Serology

Diagnostic Test

A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.

Questionnaire

Other

Data concerning personal exposure factors are collected in a questionnaire:

  • Socio-demographic factors: sex, age
  • Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital
  • Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures

Primary outcomes

  1. Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.

    Time frame: From Day 0 to Day 60

    Change of Anti-SARS-Cov2 serological status between Day 0 and Day 60, measured in blood sample.

  2. Anti-SARS-Cov2 seroconversion between Day 0 and Day 30.

    Time frame: From Day 0 to Day 30

    Change of Anti-SARS-Cov2 serological status between Day 0 and Day 30, measured in blood sample.

  3. Anti-SARS-Cov2 seroconversion between Day 30 and Day 60.

    Time frame: From Day 30 to Day 60

    Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample.

Secondary outcomes

  1. Anti-SARS-Cov2 seroprevalence at Day 0.

    Time frame: Day 0

    Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.

  2. Correlation between seroconversion and socio-demographic factors - sex

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and sex

  3. Correlation between seroconversion and socio-demographic factors - age

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and age

  4. Correlation between seroconversion and professional factors - job type

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and job type (nurse, physician, etc.)

  5. Correlation between seroconversion and professional factors - personal protective equipment type

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and personal protective equipment type

  6. Correlation between seroconversion and non-professional factors - contact with infected individuals

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and contact with infected individuals

  7. Correlation between seroconversion and non-professional factors - wearing of professional equipment

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and wearing of professional equipment

  8. Correlation between seroconversion and non-professional factors - respect of barrier gestures

    Time frame: Day 60

    Correlation between seroconversion (measured in blood sample) at Day 60 and respect of barrier gestures

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: SEROSARSCOV

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 14, 2020
Registry last updated
Mar 9, 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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