PRO-SERO-COV: Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic

Sponsor

Institut Bergonié (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04426006

Collaborator

(none)

550

Enrollment

Location

Arm

Anticipated Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2 Serum; Disease	Other: PRO-SERO-COV	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

550 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: PRO-SERO-COV Blood sample and self-administered questionnaire	Other: PRO-SERO-COV At inclusion, 3 months and 12 months : blood sample (2 x 5ml) self-administered questionnaire

Arm

Intervention/Treatment

Other: PRO-SERO-COV

Blood sample and self-administered questionnaire

Other: PRO-SERO-COV

At inclusion, 3 months and 12 months : blood sample (2 x 5ml) self-administered questionnaire

Outcome Measures

Primary Outcome Measures

Serological immune status to an infection by the SARS-CoV-2 virus [Time 0 (Inclusion)]
This will be determined from the detection of specific antibodies (immunoglobulins: IgM and IgG) or total antibodies carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.

Secondary Outcome Measures

Serological immune status to an infection by the SARS-CoV-2 virus [3 months, 12 months]
This will be determined from the detection of specific antibodies (immunoglobulins: IgM and IgG) or total antibodies carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.
Serological immune status to an infection by the SARS-CoV-2 virus [Time 0 (inclusion), 3 months, 12 months]
This will be determined from the detection of specific antibodies (immunoglobulins: IgA) carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.
The serological immune status to infection with the SARS-CoV-2 virus will also be determined from the different antibody isotypes (IgG and IgM), from a rapid diagnostic unit test (RDT). [Time 0 (inclusion), 3 months, 12 months]
Assessment using a " rapid test on cassette ".
kinetics of antibody production (IgG) against the SARS-CoV-2 virus [Time 0 (inclusion), 3 months, 12 months]
kinetics of antibody production (IgM) against the SARS-CoV-2 virus [Time 0 (inclusion), 3 months, 12 months]
kinetics of antibody production (IgA) against the SARS-CoV-2 virus [Time 0 (inclusion), 3 months, 12 months]
active COVID-19 infection [Time 0 (inclusion), 3 months, 12 months]
Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR.
symptoms of anxiety [Time 0 (inclusion), 3 months, 12 months]
GAD-7 self-questionnaire (Spitzer et al. 2006), whose score varies from 0 to 21. The recommended threshold for estimating generalized anxiety is 10 points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult 18 years-old and older.
Person in employment (on fixed-term or permanent contracts) since (at least) March 17th, 2020, the date of national implementation of containment measures in response to the COVID-19 pandemic.
Signed informed consent.
Person affiliated to a French social security regimen in accordance with Article 1121-11 of the French Public Health Code).

Exclusion Criteria:

Report of known active SARS-CoV-2 infection within 10 days prior to the date of signing the consent. Known active SARS-CoV-2 infection is defined as a positive result on a diagnostic RT-PCR test.
Presence of known symptoms suggestive of COVID-19 within 10 days prior to the date of signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive disorders (vomiting, diarrhea).
A person who is unable to follow and comply with research procedures due to geographical, social or psychological reasons.
Pregnant or breastfeeding woman.
Person deprived of their liberty, incapable or incapable of giving their consent.