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

NCT05534009 | Recruiting

• 1 other identifier: EuCARE-HCW
• Study Type: observational
• Target: 1,800
• Locations: 6 countries
• Sites: 7

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of HCW involved in the study

  To collect the higher possible number of data and biological materials from the HCWs of the participating Units

  through study completion, an average of 3 years

Study Arms (1)

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

Other: Follow up of the first known immunization event

Interventions

Follow up of the first known immunization event OTHER

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.

Heath care workers (HCW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For each subject baseline will be 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. Health CareWorkers 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. However, infections diagnosed during the first wave of the epidemic are suitable for the analysis of natural immunity to SARS-CoV-2 because vaccination was administered several months later.

You may qualify if:

• 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
• Having a signed informed consent when required by ethical approval

Sponsors & Collaborators

• Euresist Network GEIE: lead
• Centro Hospitalar Lisboa Ocidental: collaborator
• ASST Santi Paolo e Carlo: collaborator
• Bach Mai Hospital: collaborator
• Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus": collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Istituto Europeo di Oncologia: collaborator
• Vilnius University Hospital Santaros Klinikos: collaborator

Study Sites (7)

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

Biospecimen

Retention: SAMPLES WITH DNA

biological material from healthcare workers from the Units partecipating

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• CRISTINA TOSCANO, DR

  Centro Hospitalar de Lisboa Ocidental (CHLO)

  STUDY CHAIR

Central Study Contacts

FRANCESCA INCARDONA, DR

CONTACT

+393356112830; francesca.incardona@euresist.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: April 1, 2022
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: AFTER THE STUDY END NO TIME LIMIT WAS FIXED
• Access Criteria: REQUEST TO THE STUDY COORDINATOR OR TO THE PROJECTPARTNERS

Locations

PT (1); VN (1); IT (2); LI (1); DE (1); ME (1)