Sars-CoV2, Serum; Disease
Conditions
Keywords
COVID-19, Health professionals, Serology, SARS-CoV-2 Antibodies, Anxiety, ELISA
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.
Interventions
OTHERPRO-SERO-COV
At inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months | 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 |
| Number of Health Care Workers With Active COVID-19 Infection | 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. |
| Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months | 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 |
| Number of Health Care Workers With Symptoms of Anxiety at 3 Months | 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. |
| Number of Health Care Workers With Symptoms of Anxiety at 12 Months | 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. |
| Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion) | 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. |
Countries
France
Participant flow
Recruitment details
Inclusions from June 18th, 2020 to September 28th, 2020 in the Institut Bergonié (Bordeaux, France)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 517 |
| Total | 517 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12 Months | Lost to Follow-up | 38 |
| 3 Months | Lost to Follow-up | 17 |
| Inclusion | Blood sample at inclusion not done | 1 |
| Inclusion | Protocol Violation | 1 |
| Inclusion | Self-administered questionnaire at inclusion not completed | 7 |
Baseline characteristics
| Characteristic | PRO-SERO-COV | — |
|---|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 10.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 431 Participants | — |
| Sex: Female, Male Male | 86 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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 frame: Time 0 (Inclusion)
Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-SERO-COV | Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion | 18 Participants |
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 frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRO-SERO-COV | Number of Health Care Workers With Active COVID-19 Infection | 0 months | 0 Participants |
| PRO-SERO-COV | Number of Health Care Workers With Active COVID-19 Infection | 3 months | 0 Participants |
| PRO-SERO-COV | Number of Health Care Workers With Active COVID-19 Infection | 12 months | 0 Participants |
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 frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-SERO-COV | Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion) | 36 Participants |
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-SERO-COV | Number of Health Care Workers With Symptoms of Anxiety at 12 Months | 30 Participants |
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-SERO-COV | Number of Health Care Workers With Symptoms of Anxiety at 3 Months | 49 Participants |
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
Time frame: 12 months
Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion, 3 months and 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-SERO-COV | Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months | 46 Participants |
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
Time frame: 3 months
Population: Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and at 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-SERO-COV | Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months | 31 Participants |