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Clinical Trials in Portugal / NCT05534009
Recruiting Observational

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

NCT05534009 · tracked via the Priya Life Science Portugal tracker
Phase
Observational
Started
2022-04-01
Last updated
2025-09-19

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Follow up of the first known immunization event

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.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: The study subjects will be selected based on the following inclusion criteria: 1. Adult (\>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status. 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 Exclusion Criteria: NONE

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Heinrich Heine university Düsseldorf Germany Recruiting
Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo Milan Italy Recruiting
Ieo Istituto Europeo Di Oncologia Milan Italy Recruiting
Viesoji Istaiga Vilniaus Uiversiteto Ligoninė Santaros klinikos Vilnius Lithuania Recruiting
Hospital Juan Ghaham Casasus Villahermosa Mexico Recruiting
Centro Hospitalar de Lisboa Ocidental Lisbon Portugal Recruiting
Bach Mai Hospital Hanoi Vietnam Recruiting

More Euresist Network GEIE trials in Portugal

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05534009 on ClinicalTrials.gov ↗ ← All trials in Portugal