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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534009
• Other study ID #: EuCARE-HCW
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: September 2022
• Source: Euresist Network GEIE
• Contact: FRANCESCA INCARDONA, DR
• Phone: +393356112830
• Email: francesca.incardona[@]euresist.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Background: Protection from SARS-CoV-2 infection is known to occur soon after vaccination or natural disease, fading over time. Although protection from serious illness does occur, protection from infection is insufficient and the impact of each variant and of each vaccine or vaccine schedule is a matter of continuous study. Recruiting participants from countries with different vaccines and vaccine schedules is of upmost importance to analyse these relationships and breakthrough infections. Study objectives: The EuCARE-HCW study contributes with data and samples from

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
Euresist Network GEIE	ASST Santi Paolo e Carlo, Bach Mai Hospital, Centro Hospitalar Lisboa Ocidental, Heinrich-Heine University, Duesseldorf, Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus", IEO Instituto Europeo di Oncologia, Vilnius University Hospital Santaros Klinikos

Countries where clinical trial is conducted

Germany,  Italy,  Lithuania,  Mexico,  Portugal,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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