Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)

NCT05534009 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2025-09-19

No results posted yet for this study

Summary

The WP3 healthcare workers cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed SARS-CoV-2 infection. Samples from HCW are sent to central laboratories for WP2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. Eight countries will participate (Portugal, Italy, Germany, Lithuania, Georgia, Russia, Vietnam and Mexico).

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • Centro Hospitalar Lisboa Ocidental

    collaborator OTHER_GOV
  • ASST Santi Paolo e Carlo

    collaborator OTHER
  • Bach Mai Hospital

    collaborator OTHER
  • Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"

    collaborator OTHER
  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER
  • Istituto Europeo di Oncologia

    collaborator OTHER
  • Vilnius University Hospital Santaros Klinikos

    collaborator OTHER
  • Euresist Network GEIE

    lead OTHER

Principal Investigators

  • CRISTINA TOSCANO, DR · Centro Hospitalar de Lisboa Ocidental (CHLO)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-12-15
Completion
2025-12-15

Countries

  • Germany
  • Italy
  • Lithuania
  • Mexico
  • Portugal
  • Vietnam

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534009 on ClinicalTrials.gov