Trial Outcomes & Findings for Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic (NCT NCT04426006)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

526 participants

Primary outcome timeframe

Time 0 (Inclusion)

Results posted on

2025-09-03

Participant Flow

Inclusions from June 18th, 2020 to September 28th, 2020 in the Institut Bergonié (Bordeaux, France)

Participant milestones

Participant milestones
Measure	PRO-SERO-COV Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Inclusion STARTED	526
Inclusion COMPLETED	517
Inclusion NOT COMPLETED	9
3 Months STARTED	517
3 Months COMPLETED	500
3 Months NOT COMPLETED	17
12 Months STARTED	500
12 Months COMPLETED	462
12 Months NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	PRO-SERO-COV Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Inclusion Protocol Violation	1
Inclusion Self-administered questionnaire at inclusion not completed	7
Inclusion Blood sample at inclusion not done	1
3 Months Lost to Follow-up	17
12 Months Lost to Follow-up	38

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRO-SERO-COV n=517 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Age, Continuous	42.2 years STANDARD_DEVIATION 10.8 • n=517 Participants
Sex: Female, Male Female	431 Participants n=517 Participants
Sex: Female, Male Male	86 Participants n=517 Participants

PRIMARY outcome

Timeframe: Time 0 (Inclusion)

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available 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

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=517 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion	18 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and 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

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=500 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months	31 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion, 3 months and 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

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=462 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months	46 Participants

SECONDARY outcome

Timeframe: Time 0 (inclusion), 3 months, 12 months

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion (for 0 month visit) , 3 months (for 3 months visit) and 12 months (for 12 months visit)

Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR.

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=517 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Number of Health Care Workers With Active COVID-19 Infection 0 months	0 Participants
Number of Health Care Workers With Active COVID-19 Infection 3 months	0 Participants
Number of Health Care Workers With Active COVID-19 Infection 12 months	0 Participants

SECONDARY outcome

Timeframe: Time 0 (inclusion)

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at 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.

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=460 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)	36 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 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.

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=442 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Number of Health Care Workers With Symptoms of Anxiety at 3 Months	49 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 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.

Outcome measures

Outcome measures
Measure	PRO-SERO-COV n=413 Participants Blood sample and self-administered questionnaire PRO-SERO-COV: At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Number of Health Care Workers With Symptoms of Anxiety at 12 Months	30 Participants

Adverse Events

PRO-SERO-COV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Simone Mathoulin-Pelissier

Institut Bergonié

Phone: 0556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place