Covid19ICONENCT05011344
Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities
A study testing Blood sample in people with Covid19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, 13354
Laetitia NINOVE, Laetitia.NINOVE@ap-hm.fr
About this study
Official title: Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities
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).
Read the 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.
- Conditions
- Covid19
- Being tested
- Blood sample
- Keywords
- serology, healthcare workers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Seroneutralization and Elisa tests
| Study group | Role | What they receive |
|---|---|---|
| Exposed hospital staff | Experimental | 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. Receives: Other: Blood sample |
| 'Non-exposed' hospital workers | Other | 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. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4, 8 and 12 months follow-up visits after the initial visit
Secondary outcomes (5)
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).
Measured: 4, 8 and 12 months 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.
Measured: 12 months after the initial visit
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.
Measured: 4, 8 and 12 months follow-up visits after the initial visit
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
Measured: 12 months
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.
Measured: 4, 8 and 12 months follow-up visits after the initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Jul 2020
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO-PRADALIE, MD, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011344
- Sponsor's protocol ID
- 2020-39
- Acronym
- ICONE
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities
- ClinicalTrials.gov ID
- NCT05011344
- Acronym / sponsor ID
- ICONE / 2020-39
- Conditions
- Covid19
- Keywords
- serology, healthcare workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed hospital staff | Experimental | Other: Blood sampleHospital 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. |
| 'Non-exposed' hospital workers | Other | Other: Blood sampleHospital 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleSeroneutralization and Elisa tests | Other | 'Non-exposed' hospital workers, Exposed hospital staff |
Primary outcome
To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
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.
5 secondary outcomes
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.
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
Compare immunization profiles
Time frame: 12 months after the initial visit
Compare the seroprevalence of SARS-CoV-2 and the kinetics of immunization between two groups (exposed hospital workers and a less exposed hospital workers).
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
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.
Time frame: 12 months
Record COVID-19 seroprevalences established by ELISA at different time points: inclusion, 4 months, 8 months, and 12 months after inclusion.
Time frame: 4, 8 and 12 months follow-up visits after the initial visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie GARRIDO-PRADALIE, MD study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Covid19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laetitia Ninove, MCU-PH (+33 4 91 83 20 66, Laetitia.Ninove@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the level of immunization (seroprevalence) to COVID-19 as determined by the seroneutralization test in a population of exposed hospital workers (time frame: 4, 8 and 12 months follow-up visits after the initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.