Official Title
Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
Brief Summary

The WP3 hospitalized cohort in EuCARE is an observational multicentre study includingcollection of retrospective (historical) and prospective data from hospitalized COVID-19patients followed at 12 clinics from 11 countries from 4 continents. In a subset ofpatients, peripheral blood, viral isolates and/or viral sequences are collected foranalysis in WP2 with regards to neutralising antibodies, cellular immunity and SARS-CoV-2diagnostics. Data and results from analysis of biological material will be analysed bybiostatistical methods and with artificial intelligence in WP5. This analysis will focuson the impact on clinical outcome of viral variants / viral sequences as well as thevaccines used and the vaccination schedules.

Detailed Description

Background: Since the start of the COVID-19 pandemic, novel SARS-CoV-2 variants of
concern have emerged, some of which have become largely dominant including the B.1.1.7
(alpha), the B.1.617 (delta) and more recently the B.1.1.529 (omicron). The clinical
implications of the different variants in unvaccinated and vaccinated persons are still
not adequately characterized. The detailed understanding of the interplay between the
variants, vaccine immune responses and disease severity is still scarce.

Study objectives:

Overall objectives are:

- to collect data and/or biological material from COVID-19 in-patients in a diverse
setting of 12 clinics in 11 countries and 4 continents

- to analyse the clinical course of COVID-19 in in-patients in relation to the viral
characteristics

- to analyse the clinical course of COVID-19 in in-patients in relation to vaccines
used and vaccination schedules

- to deliver recommendations for optimized clinical management and treatment with
special consideration to viral characteristics and to used vaccines

Specific objectives are:

- To describe the patterns of clinical symptoms, therapeutic interventions and
clinical outcome in patients hospitalized from 12 hospitals/clinics, in 11 countries
and 4 continents.

- To assess the impact of viral variants / viral sequences on the clinical outcome
measured as all-cause in-hospital mortality, non-invasive mechanical
ventilation/high-flow nasal oxygen, mechanical ventilation, admission to intensive
care unit, length of time in intensive care and overall length of hospitalization.

- To assess the impact of different vaccines and vaccination schedules on the clinical
outcome measured as all-cause in-hospital mortality, non-invasive mechanical
ventilation/high-flow nasal oxygen, mechanical ventilation, admission to intensive
care unit, length of time in intensive care and overall length of hospitalization.

- To assess the impact of viral variants / sequences in response to treatment
interventions and the associated clinical outcome

- To assess the impact of different vaccines and vaccination schedules in response to
treatment interventions and the associated clinical outcome

- To provide WP2 in EuCARE with biological material for further studies on viral
characteristics and associated immune responses

- To provide WP5 in EuCARE with data for further studies using artificial intelligence

Recruiting
COVID-19

Other: standard of care

The patient will be treated following the satndard of care in the participating units

Eligibility Criteria

Inclusion Criteria:

- Hospitalized adult (>18 years) patients including patients in the emergency ward

- Positive for SARS-CoV-2 by PCR any time from 14 days before admission date until
hospital discharge. Both first and recurrent episodes of COVID-19 will be included.

- Having a signed informed consent when required by ethical approval

Exclusion Criteria: none

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Italy
Kenya
Lithuania
Mexico
Portugal
Sweden
United Kingdom
Vietnam
Locations

Heinrich-Heine-Universität Düsseldorf
Düsseldorf, Germany

ASST Santi Paolo e Carlo
Milan, Lombardia, Italy

University of Rome Tor Vergata
Rome, Italy

Kenya Medical Research Institute (KEMRI)
Nairobi, Kenya

Vilnius universiteto ligoninė Santaros klinikos
Vilnius, Lithuania

Regional Hospital Dr. Juan Graham Casasús, Villahermosa
Villahermosa, Mexico

Centro Hospitalar Lisboa Ocidental
Lisboa, Portugal

Karolinska Institutet
Stockholm, Sweden

Poole University Hospitals, Dorset
Poole, United Kingdom

Bach Mai Hospital
Hanoi, Vietnam

Contacts

FRANCESCA INCARDONA Project Coordinator
+393356112830
francesca.incardona@euresist.org

ANDERS Sönnerborg, Prof, Study Chair
Karolinska Institutet

Euresist Network GEIE
NCT Number
MeSH Terms
COVID-19