Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    1000
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 29 August 2021

Summary

To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

Description

Current studies on seroconversion and the time course of immunity following exposure to SARS-CoV-2 do not document: i) Seroconversion in populations in repeated and frequent contact with patients; ii) The temporal dynamics of seroconversion at medium term. These two elements are however fundamental in the comprehension and management of this epidemic or of its potential resurgence in the following months and years.

Objective: To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

Secondary objectives:

  1. Determine the kinetics of the protective response over 12 months (4 times).
  2. Compare immunization profiles according to: gender, age, lockdown, blood type, occupational class, exposure, asymptomatic/symptomatic.
  3. Compare immunization kinetics between exposed and low-exposure hospital workers.
  4. To determine the characteristics of the ELISA test in comparison with the reference test (seroneutralization).

Perspectives

  • To provide a reliable, affordable and faster serological test.
  • Understanding of the natural evolution of seroprotection in a population over time.
  • Sensitization to plasma donation for seropositive patients.

Details
Condition COVID19
Treatment Blood sample
Clinical Study IdentifierNCT05011344
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on29 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort of exposed hospital workers
Hospital caregiver or non-clinician agreeing to participate in the study defined as: Healthcare personnel (physician, nurse, orderly, physical therapist, midwives) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, COVID-19 units
Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection
Person affiliated to a social security system
Cohort of 'unexposed' hospital workers
Hospital care worker (physician, nurse, orderly) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection
Person affiliated with a social security system

Exclusion Criteria

Hospital worker declining to participate If the hospital worker changes assignment after the first collection, he/she remains in the exposed cohort
Protected adult
Person under legal guardianship or curatorship
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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