Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)
NCT ID: NCT05534009
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1800 participants
OBSERVATIONAL
2022-04-01
2025-12-15
Brief Summary
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Detailed Description
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HCW to EuCARE-IMMUNITY study that will analyse the NtAb and CMI to different SARS- CoV-2 variants following any combination of natural infection and vaccination. Specific
objectives include:
* to collect data and biological material from COVID-19 healthcare workers in 9 clinics from 8 countries and 3 continents.
* Enrolment of HCW with an immunogenic event, either vaccination or infection.
* Periodic collection of serum and whole blood every 4 months since enrolment and during 12-24 months (depending on how long immunity persists).
* Sample preparation, storage and shipment to central EuCARE laboratories where WP2 study group will analyse natural and artificial immunity to SARS-CoV-2 variants (EuCARE-IMMUNITY), namely:
* Analyse the magnitude, breadth and duration of immunity following natural infection and/or vaccination.
* Define the cross-immunity among the different viral variants.
* Analyse the immune escape in a comprehensive set of combinations of vaccines and natural infection(s).
* To accomplish the above objectives, WP2 will test:
* Neutralising antibodies
* Cellular immunity
* Viral sequences
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Heath care workers (HCW)
Adult (\>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status. For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
Follow up of the first known immunization event
The baseline for enrolment into the study is defined by the occurrence of the first known immunization event, either natural infection or vaccination. The follow-up is planned to last 24 months with respect to this baseline. In subjects with natural infection, the viral variant must be determined for each prospective case by analysis of a nasopharyngeal swab obtained as soon as possible at diagnosis. For historical cases where the variant was not determined and a contemporary nasopharyngeal swab has not been stored, the viral variant may be inferred when a specific variant was dominating the geographic area according to official records available at local health agencies. However, the variant assignment will be labelled as putative, rather than proved.
HCWs can be enrolled in the category of:
(i) vaccination not followed by any later infection, (ii) infection followed by vaccination and (iii) vaccination followed by infection.
Interventions
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Follow up of the first known immunization event
The baseline for enrolment into the study is defined by the occurrence of the first known immunization event, either natural infection or vaccination. The follow-up is planned to last 24 months with respect to this baseline. In subjects with natural infection, the viral variant must be determined for each prospective case by analysis of a nasopharyngeal swab obtained as soon as possible at diagnosis. For historical cases where the variant was not determined and a contemporary nasopharyngeal swab has not been stored, the viral variant may be inferred when a specific variant was dominating the geographic area according to official records available at local health agencies. However, the variant assignment will be labelled as putative, rather than proved.
HCWs can be enrolled in the category of:
(i) vaccination not followed by any later infection, (ii) infection followed by vaccination and (iii) vaccination followed by infection.
Eligibility Criteria
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Inclusion Criteria
2. For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
3. Having a signed informed consent when required by ethical approval
18 Years
ALL
No
Sponsors
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Centro Hospitalar Lisboa Ocidental
OTHER_GOV
ASST Santi Paolo e Carlo
OTHER
Bach Mai Hospital
OTHER
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Istituto Europeo di Oncologia
OTHER
Vilnius University Hospital Santaros Klinikos
OTHER
Euresist Network GEIE
OTHER
Responsible Party
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Principal Investigators
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CRISTINA TOSCANO, DR
Role: STUDY_CHAIR
Centro Hospitalar de Lisboa Ocidental (CHLO)
Locations
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Heinrich Heine university
Düsseldorf, , Germany
Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo
Milan, , Italy
Ieo Istituto Europeo Di Oncologia
Milan, , Italy
Viesoji Istaiga Vilniaus Uiversiteto Ligoninė Santaros klinikos
Vilnius, , Lithuania
Hospital Juan Ghaham Casasus
Villahermosa, , Mexico
Centro Hospitalar de Lisboa Ocidental
Lisbon, , Portugal
Bach Mai Hospital
Hanoi, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EuCARE-HCW
Identifier Type: -
Identifier Source: org_study_id
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