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

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring serology, healthcare workers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique Des Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exposed hospital staff

'Non-exposed' hospital workers

Arm Description

Hospital health care or non-health care staff willing to participate in the study: Healthcare personnel (physician, nurse, caregiver) 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, radiology, 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.

Hospital health care worker (physician, nurse, caregiver) 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.

Outcomes

Primary Outcome Measures

To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
Positive seroneutralization test result: the threshold of positivity is set at 40, i.e. any serum with a seroneutralizing value greater than or equal to 40 will be considered positive.

Secondary Outcome Measures

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.
The kinetics of "seroprevalence" will be defined by the results of the seroneutralization test at 4 time-points (4, 8 and 12 month follow-up visits after the initial visit).
Compare immunization profiles
Combine multiple measurement in order to compare immunization profiles (symptomatic status,individual characteristics, i.e, gender, age range, condition of lockdown, blood type; professional characteristics and possible clinical signs.
Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).
Compare between groups the results of the seroneutralization test over time.
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.
ELISA's test positivity will be defined with reference to the manufacturer's recommendations. For a ratio OD of the tested sample / kit control: <0.9: negative test Between 0.9 and 1.1: unspecified test >1.1: positive test The result will be processed under two modalities: negative/indeterminate/positive and quantitative
Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.
The technical and predictive characteristics of the ELISA test (sensitivity, specificity, positive predictive value and negative predictive value) are documented by reference to the serum neutralisation test.

Full Information

First Posted
August 9, 2021
Last Updated
August 18, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05011344
Brief Title
Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities
Acronym
ICONE
Official Title
Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Determine the kinetics of the protective response over 12 months (4 times). Compare immunization profiles according to: gender, age, lockdown, blood type, occupational class, exposure, asymptomatic/symptomatic. Compare immunization kinetics between exposed and low-exposure hospital workers. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
serology, healthcare workers

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposed hospital staff
Arm Type
Experimental
Arm Description
Hospital health care or non-health care staff willing to participate in the study: Healthcare personnel (physician, nurse, caregiver) 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, radiology, 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.
Arm Title
'Non-exposed' hospital workers
Arm Type
Other
Arm Description
Hospital health care worker (physician, nurse, caregiver) 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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Seroneutralization and Elisa tests
Primary Outcome Measure Information:
Title
To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
Description
Positive seroneutralization test result: the threshold of positivity is set at 40, i.e. any serum with a seroneutralizing value greater than or equal to 40 will be considered positive.
Time Frame
4, 8 and 12 months follow-up visits after the initial visit
Secondary Outcome Measure Information:
Title
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.
Description
The kinetics of "seroprevalence" will be defined by the results of the seroneutralization test at 4 time-points (4, 8 and 12 month follow-up visits after the initial visit).
Time Frame
4, 8 and 12 months follow-up visits after the initial visit
Title
Compare immunization profiles
Description
Combine multiple measurement in order to compare immunization profiles (symptomatic status,individual characteristics, i.e, gender, age range, condition of lockdown, blood type; professional characteristics and possible clinical signs.
Time Frame
12 months after the initial visit
Title
Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).
Description
Compare between groups the results of the seroneutralization test over time.
Time Frame
4, 8 and 12 months follow-up visits after the initial visit
Title
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.
Description
ELISA's test positivity will be defined with reference to the manufacturer's recommendations. For a ratio OD of the tested sample / kit control: <0.9: negative test Between 0.9 and 1.1: unspecified test >1.1: positive test The result will be processed under two modalities: negative/indeterminate/positive and quantitative
Time Frame
12 months
Title
Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.
Description
The technical and predictive characteristics of the ELISA test (sensitivity, specificity, positive predictive value and negative predictive value) are documented by reference to the serum neutralisation test.
Time Frame
4, 8 and 12 months follow-up visits after the initial visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laetitia Ninove, MCU-PH
Phone
+33 4 91 83 20 66
Email
Laetitia.Ninove@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie GARRIDO-PRADALIE, MD
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Des Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia NINOVE
Email
Laetitia.NINOVE@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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

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