Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standard of care.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy, Kenya, Lithuania, Mexico +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The WP3 hospitalized cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data from hospitalized COVID-19 patients followed at 12 clinics from 11 countries from 4 continents. In a subset of patients, peripheral blood, viral isolates and/or viral sequences are collected for analysis in WP2 with regards to neutralising antibodies, cellular immunity and SARS-CoV-2 diagnostics. Data and results from analysis of biological material will be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on clinical outcome of viral variants / viral sequences as well as the vaccines 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
Interventions
- Other standard of care
The patient will be treated following the satndard of care in the participating units
Primary outcome measures
- Severity of SARS-CoV-2 infection [Time frame: through study completion, an average of 4 year]
- In-hospital mortality [Time frame: through study completion, an average of 4 year]
- ICU Admissions and Discharges [Time frame: through study completion, an average of 4 year]
- Rate of Invasive and Non invasive mechanical ventilation [Time frame: through study completion, an average of 4 year]
Secondary outcome measures (3)
- Frequency and type of Renal replacement therapies (RRT, dialysis) [Time frame: through study completion, an average of 4 year]
- Frequency of Blood transfusions [Time frame: through study completion, an average of 4 year]
- Frequency of ECMO Frequency of ECMO [Time frame: through study completion, an average of 4 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- ASST Santi Paolo e Carlo — Milan
- University of Rome Tor Vergata — Rome
Germany · 1 center
- Heinrich-Heine-Universität Düsseldorf — Düsseldorf
Kenya · 1 center
- Kenya Medical Research Institute (KEMRI) — Nairobi
Lithuania · 1 center
- Vilnius universiteto ligoninė Santaros klinikos — Vilnius
Mexico · 1 center
- Regional Hospital Dr. Juan Graham Casasús, Villahermosa — Villahermosa
Portugal · 1 center
- Centro Hospitalar Lisboa Ocidental — Lisbon
Sweden · 1 center
- Karolinska Institutet — Stockholm
United Kingdom · 1 center
- Poole University Hospitals, Dorset — Poole
Vietnam · 1 center
- Bach Mai Hospital — Hanoi
Publications
- Hedberg P, Varisco B, Bai F, Sonnerborg A, Naucler P, Pfeifer N, Cozzi-Lepri A, Ceccherini-Silberstein F, Naumovas D, Drobniewski F, Jensen BO, Toscano C, Parczewski M, Quintanares GHR, Mwau M, Pinto JA, Incardona F, Mommo C, Marchetti G. EuCARE-hospitalised study protocol: a cohort study of patients hospitalised with COVID-19 in the EuCARE project. BMC Infect Dis. 2023 Oct 16;23(1):690. doi: 10.1 PMID 37845624
Identifiers
NCT: NCT05463380 · EuCARE-HOSPITALISED study