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Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic (PRO-SERO-COV)

I

Institut Bergonié

Status

Completed

Conditions

Sars-CoV2
Serum; Disease

Treatments

Other: PRO-SERO-COV

Study type

Interventional

Funder types

Other

Identifiers

NCT04426006
IB 2020-01
2020-A01355-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

526 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

526 participants in 1 patient group

PRO-SERO-COV
Other group
Description:
Blood sample and self-administered questionnaire
Treatment:
Other: PRO-SERO-COV

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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