Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - Clinical Trial for Sars-CoV2 | NCT04426006

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PRO-SERO-COV

About this trial

This is an interventional prevention trial for Sars-CoV2 focused on measuring COVID-19, Health professionals, Serology, SARS-CoV-2 Antibodies, Anxiety, ELISA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Institut Bergonié

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PRO-SERO-COV

Arm Description

Blood sample and self-administered questionnaire

Outcomes

Primary Outcome Measures

Serological immune status to an infection by the SARS-CoV-2 virus

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

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

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).

Assessment using a " rapid test on cassette ".

kinetics of antibody production (IgG) against the SARS-CoV-2 virus

kinetics of antibody production (IgM) against the SARS-CoV-2 virus

kinetics of antibody production (IgA) against the SARS-CoV-2 virus

active COVID-19 infection

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

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

Full Information

NCT ID

NCT04426006

First Posted

June 9, 2020

Last Updated

February 2, 2022

Sponsor

Institut Bergonié

1. Study Identification

Unique Protocol Identification Number

NCT04426006

Brief Title

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

Acronym

PRO-SERO-COV

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

January 1, 2022 (Actual)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Bergonié

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sars-CoV2, Serum; Disease

Keywords

COVID-19, Health professionals, Serology, SARS-CoV-2 Antibodies, Anxiety, ELISA

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRO-SERO-COV

Arm Type

Other

Arm Description

Blood sample and self-administered questionnaire

Intervention Type

Other

Intervention Name(s)

PRO-SERO-COV

Intervention Description

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

Primary Outcome Measure Information:

Title

Serological immune status to an infection by the SARS-CoV-2 virus

Description

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.

Time Frame

Time 0 (Inclusion)

Secondary Outcome Measure Information:

Title

Serological immune status to an infection by the SARS-CoV-2 virus

Description

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.

Time Frame

3 months, 12 months

Title

Serological immune status to an infection by the SARS-CoV-2 virus

Description

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.

Time Frame