N/A
N=526
Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic
Sars-CoV2 · Serum; Disease
Bottom Line
View on ClinicalTrials.gov: NCT04426006 ↗Enrolled (actual)
526
Serious AEs
—
Results posted
Jan 2024
Primary outcome: Primary: Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRO-SERO-COV (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion |
18 | — |
| SECONDARY Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months |
31 | — |
| SECONDARY Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months |
46 | — |
| SECONDARY Number of Health Care Workers With Active COVID-19 Infection |
0; 0; 0 | — |
| SECONDARY Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion) |
36 | — |
| SECONDARY Number of Health Care Workers With Symptoms of Anxiety at 3 Months |
49 | — |
| SECONDARY Number of Health Care Workers With Symptoms of Anxiety at 12 Months |
30 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04426006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.