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

Sars-CoV2 Clinical Trial

— SEROSARSCOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387838
• Other study ID #: 2020-COVID19-10
• Secondary ID: 2020-A01028-31
• Status: Completed
• Start date: May 14, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: March 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 845
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Sars-CoV2

Intervention

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

Locations

Country	Name	City	State
France	Hôpital d'Instuction des Armées Sainte-Anne	Toulon
France	Hôpital d'Instruction des Armées Robert Picqué	Villenave-d'Ornon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Anti-SARS-Cov2 seroprevalence at Day 0.	Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.	Day 0
Secondary	Correlation between seroconversion and socio-demographic factors - sex	Correlation between seroconversion (measured in blood sample) at Day 60 and sex	Day 60
Secondary	Correlation between seroconversion and socio-demographic factors - age	Correlation between seroconversion (measured in blood sample) at Day 60 and age	Day 60
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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