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.
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
Other: standard of care
The patient will be treated following the satndard of care in the participating units
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
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
FRANCESCA INCARDONA Project Coordinator
+393356112830
francesca.incardona@euresist.org
ANDERS Sönnerborg, Prof, Study Chair
Karolinska Institutet