Clinical trial NCT05011344: Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities
Official title: Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: serology
healthcare workers
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
timeFrame: 4, 8 and 12 months follow-up visits after the initial visit
Secondary outcomes:
measure: Kinetics of the protective antibody immune response (protective immunization against SARS-CoV-2 COVID-19) in a population of exposed hospital workers over a 12-month period.
timeFrame: 4, 8 and 12 months follow-up visits after the initial visit
measure: Compare immunization profiles
timeFrame: 12 months after the initial visit
measure: Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).
timeFrame: 4, 8 and 12 months follow-up visits after the initial visit
measure: Identify the technical (sensitivity and specificity) and predictive (positive and negative predictive values) characteristics of the ELISA test evaluated in comparison with the reference test (serum neutralization) in the population of interest.
timeFrame: 12 months
measure: Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.
timeFrame: 4, 8 and 12 months follow-up visits after the initial visit
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Des Hopitaux de Marseille
Study officials:
affiliation: APHM
name: Emilie GARRIDO-PRADALIE, MD
role: STUDY_DIRECTOR
References: