Sars-CoV2PRO-SERO-COVNCT04426006
Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic
A study testing PRO-SERO-COV in people with Sars-CoV2 and Serum; Disease, run by Institut Bergonié at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2, Serum; Disease
- What is being tested?
- PRO-SERO-COV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2020to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PRO-SERO-COV
- Keywords
- COVID-19, Health professionals, Serology, SARS-CoV-2 Antibodies, Anxiety, ELISA
- Medical subject headings
- Disease, COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-SERO-COVOther
At inclusion, 3 months and 12 months :
- blood sample (2 x 5ml)
- self-administered questionnaire
| Study group | Role | What they receive |
|---|---|---|
| PRO-SERO-COV | Other | Blood sample and self-administered questionnaire Receives: Other: PRO-SERO-COV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 3 months
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
Measured: 12 months
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.
Measured: Time 0 (inclusion), 3 months, 12 months
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.
Measured: Time 0 (inclusion)
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.
Measured: 3 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start18 Jun 2020
- Primary completion26 Jan 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone MATHOULIN-PELISSIER, MD, PhD, Study chair, s.mathoulin@bordeaux.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426006
- Sponsor's protocol ID
- IB 2020-01
- Other IDs
- 2020-A01355-34
- Acronym
- PRO-SERO-COV
- Status last verified
- Apr 2023
- First submitted
- 9 Jun 2020
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37297553
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04426006
- Acronym / sponsor ID
- PRO-SERO-COV / IB 2020-01
- Conditions
- Sars-CoV2, Serum; Disease
- Keywords
- COVID-19, Health professionals, Serology, SARS-CoV-2 Antibodies, Anxiety, ELISA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRO-SERO-COV | Other | Other: PRO-SERO-COVBlood sample and self-administered questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-SERO-COVAt inclusion, 3 months and 12 months : * blood sample (2 x 5ml) * self-administered questionnaire | Other | PRO-SERO-COV |
Primary outcome
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
6 secondary outcomes
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months
Time frame: 3 months
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months
Time frame: 12 months
Number of Health Care Workers With Active COVID-19 Infection
Time frame: Time 0 (inclusion), 3 months, 12 months
Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)
Time frame: Time 0 (inclusion)
Number of Health Care Workers With Symptoms of Anxiety at 3 Months
Time frame: 3 months
Number of Health Care Workers With Symptoms of Anxiety at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37297553Richez 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.
- Individual participant dataSharing planned: No
Related trials for Sars-CoV2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone MATHOULIN-PELISSIER, MD, PhD study chair
s.mathoulin@bordeaux.unicancer.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRO-SERO-COV in people with Sars-CoV2 and Serum; Disease, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion (time frame: Time 0 (Inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.