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

NCT04426006 | Completed Results DMC

• 2 other identifiers: IB 2020-012020-A01355-34
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2; Serum; Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months

  3 months

• Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months

  12 months

• Number of Health Care Workers With Active COVID-19 Infection

  Time 0 (inclusion), 3 months, 12 months

• Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)

  Time 0 (inclusion)

• Number of Health Care Workers With Symptoms of Anxiety at 3 Months

  3 months

Study Arms (1)

PRO-SERO-COV

OTHER

Blood sample and self-administered questionnaire

Other: PRO-SERO-COV

Interventions

PRO-SERO-COV OTHER

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

PRO-SERO-COV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 37297553 BACKGROUND

MeSH Terms

Conditions

Disease; COVID-19; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Results Point of Contact

• Title: Pr Simone Mathoulin-Pelissier
• Organization: Institut Bergonié

S.Mathoulin@bordeaux.unicancer.fr

0556333333

Study Officials

• Simone MATHOULIN-PELISSIER, MD, PhD

  s.mathoulin@bordeaux.unicancer.fr

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 18, 2020
• Primary Completion: January 26, 2021
• Study Completion: October 4, 2021
• Last Updated: September 3, 2025
• Results First Posted: January 12, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)