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

NCT04387838 | Completed

• 2 other identifiers: 2020-COVID19-102020-A01028-31
• Study Type: observational
• Target: 845
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Anti-SARS-Cov2 seroprevalence at Day 0.

  Day 0

• Correlation between seroconversion and socio-demographic factors - sex

  Day 60

• Correlation between seroconversion and socio-demographic factors - age

  Day 60

• Correlation between seroconversion and professional factors - job type

  Day 60

• Correlation between seroconversion and professional factors - personal protective equipment type

  Day 60

Study Arms (1)

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; Other: Questionnaire

Interventions

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.

Anti-SARS-CoV2 serological status

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

Anti-SARS-CoV2 serological status

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Army Training Hospital staff

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (2)

Hôpital d'Instuction des Armées Sainte-Anne

Toulon, 83800, France

Location

Hôpital d'Instruction des Armées Robert Picqué

Villenave-d'Ornon, 33882, France

Location

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 13, 2020
• First Posted: May 14, 2020
• Study Start: May 14, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

FR (2)