Skip to main content
OpenTrials
Completed

NCT Number: NCT04426006

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sars-CoV2 Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Disease Infections Lung Diseases Mental Disorders Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Serum; Disease Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRO-SERO-COV

Other

At inclusion, 3 months and 12 months :

  • blood sample (2 x 5ml)
  • self-administered questionnaire

Primary outcomes

  1. Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion

    Time frame: Time 0 (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

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

  3. Number of Health Care Workers With Active COVID-19 Infection

    Time frame: 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.

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

    Time frame: Time 0 (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.

  5. Number of Health Care Workers With Symptoms of Anxiety at 3 Months

    Time frame: 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.

  6. Number of Health Care Workers With Symptoms of Anxiety at 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study 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

Acronym: PRO-SERO-COV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.