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

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

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.

Study Overview

• Status: Completed
• Conditions: Sars-CoV2; Serum; Disease
• Intervention / Treatment: Other: PRO-SERO-COV

• Study Type: Interventional
• Enrollment (Actual): 526
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adult 18 years-old and older.
2. 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.
3. Signed informed consent.
4. Person affiliated to a French social security regimen in accordance with Article 1121-11 of the French Public Health Code).

Exclusion Criteria:

1. 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.
2. 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).
3. A person who is unable to follow and comply with research procedures due to geographical, social or psychological reasons.
4. Pregnant or breastfeeding woman.
5. Person deprived of their liberty, incapable or incapable of giving their consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion	Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as : Positive in case of positive ELISA test AND/OR positive ECLIA test; Negative otherwise	Time 0 (Inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months	Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. Serum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France). These ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as : Positive in case of positive ELISA test AND/OR positive ECLIA test; Negative otherwise	3 months
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months	Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit. ECLIA test was carried out in the medical biology laboratory of the Institut Bergonié. Serological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patients and defined as : Positive in case of positive ECLIA test; Negative otherwise	12 months
Number of Health Care Workers With 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.	Time 0 (inclusion), 3 months, 12 months
Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)	Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.	Time 0 (inclusion)
Number of Health Care Workers With Symptoms of Anxiety at 3 Months	Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.	3 months
Number of Health Care Workers With Symptoms of Anxiety at 12 Months	Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.	12 months

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Study Chair: Simone MATHOULIN-PELISSIER, MD, PhD, s.mathoulin@bordeaux.unicancer.fr

Publications and helpful links

General Publications

• Richez B, Cantarel C, Durrieu F, Soubeyran I, Blanchi J, Pernot S, Chakiba Brugere C, Roubaud G, Cousin S, Etienne G, Floquet A, Babre F, Rivalan J, Lalet C, Narbonne M, Belaroussi Y, Bellera C, Mathoulin-Pelissier S. One-Year Follow-Up of Seroprevalence of SARS-CoV-2 Infection and Anxiety among Health Workers of a French Cancer Center: The PRO-SERO-COV Study. Int J Environ Res Public Health. 2023 May 25;20(11):5949. doi: 10.3390/ijerph20115949.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): January 26, 2021
• Study Completion (Actual): October 4, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; COVID-19; Health professionals; Serology; SARS-CoV-2 Antibodies; ELISA
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Anxiety Disorders; Disease
• Other Study ID Numbers: IB 2020-01; 2020-A01355-34 (Other Identifier: ANSM ID-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No