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

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.

Study Overview

• Status: Completed
• Conditions: Sars-CoV2
• Intervention / Treatment: Diagnostic test: Anti-SARS-CoV2 Serology; Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 845

Contacts and Locations

Study Locations

• France
  • Toulon, France, 83800
    • Hôpital d'Instuction des Armées Sainte-Anne
  • Villenave-d'Ornon, France, 33882
    • Hôpital d'Instruction des Armées Robert Picqué

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of army training hospital staff who have not already been confirmed Covid-19 positive and who are not taking any treatment relative with Covid-19.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Anti-SARS-CoV2 serological status; At Day 0, a blood sample is collected by venipuncture and a questionnaire is being filled. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France. For individuals who are anti-SARS-CoV2 seronegative, the same intervention is made at Day 30 and D60. For the individuals who are anti-SARS-CoV2 seropositive, the study follow-up is stopped.

Diagnostic test: Anti-SARS-CoV2 Serology; 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.; Other: Questionnaire; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-SARS-Cov2 seroconversion between Day 0 and Day 60.	Change of Anti-SARS-Cov2 serological status between Day 0 and Day 60, measured in blood sample.	From Day 0 to Day 60
Anti-SARS-Cov2 seroconversion between Day 0 and Day 30.	Change of Anti-SARS-Cov2 serological status between Day 0 and Day 30, measured in blood sample.	From Day 0 to Day 30
Anti-SARS-Cov2 seroconversion between Day 30 and Day 60.	Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample.	From Day 30 to Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-SARS-Cov2 seroprevalence at Day 0.	Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.	Day 0
Correlation between seroconversion and socio-demographic factors - sex	Correlation between seroconversion (measured in blood sample) at Day 60 and sex	Day 60
Correlation between seroconversion and socio-demographic factors - age	Correlation between seroconversion (measured in blood sample) at Day 60 and age	Day 60
Correlation between seroconversion and professional factors - job type	Correlation between seroconversion (measured in blood sample) at Day 60 and job type (nurse, physician, etc.)	Day 60
Correlation between seroconversion and professional factors - personal protective equipment type	Correlation between seroconversion (measured in blood sample) at Day 60 and personal protective equipment type	Day 60
Correlation between seroconversion and non-professional factors - contact with infected individuals	Correlation between seroconversion (measured in blood sample) at Day 60 and contact with infected individuals	Day 60
Correlation between seroconversion and non-professional factors - wearing of professional equipment	Correlation between seroconversion (measured in blood sample) at Day 60 and wearing of professional equipment	Day 60
Correlation between seroconversion and non-professional factors - respect of barrier gestures	Correlation between seroconversion (measured in blood sample) at Day 60 and respect of barrier gestures	Day 60

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-COVID19-10; 2020-A01028-31 (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