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

Sars-CoV2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426006
• Other study ID #: IB 2020-01
• Secondary ID: 2020-A01355-34
• Status: Completed
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: October 4, 2021

Study information

• Verified date: April 2023
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: October 4, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV2
• Serum; Disease

Intervention

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

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

References & Publications (1)

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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