Clinical trial NCT04426006: Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sars-CoV2
Serum; Disease
Keywords: COVID-19
Health professionals
Serology
SARS-CoV-2 Antibodies
Anxiety
ELISA
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion
timeFrame: Time 0 (Inclusion)
Secondary outcomes:
measure: Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months
timeFrame: 3 months
measure: Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months
timeFrame: 12 months
measure: Number of Health Care Workers With Active COVID-19 Infection
timeFrame: Time 0 (inclusion), 3 months, 12 months
measure: Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)
timeFrame: Time 0 (inclusion)
measure: Number of Health Care Workers With Symptoms of Anxiety at 3 Months
timeFrame: 3 months
measure: Number of Health Care Workers With Symptoms of Anxiety at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
affiliation: s.mathoulin@bordeaux.unicancer.fr
name: Simone MATHOULIN-PELISSIER, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.