Clinical trial NCT05463380: Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
Official title: Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Euresist Network GEIE
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Centro Hospitalar Lisboa Ocidental
name: Heinrich-Heine University, Duesseldorf
name: ASST Santi Paolo e Carlo
name: Imperial College London
name: Vilnius University Hospital Santaros Klinikos
name: University of Rome Tor Vergata
name: Bach Mai Hospital
name: Kenya Medical Research Institute
name: Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
name: University Hospitals Dorset NHS Foundation Trust
First posted: 2022-07-19
Enrollment: 22000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

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

Primary outcomes:
measure: Severity of SARS-CoV-2 infection
timeFrame: through study completion, an average of 4 year
measure: In-hospital mortality
timeFrame: through study completion, an average of 4 year
measure: ICU Admissions and Discharges
timeFrame: through study completion, an average of 4 year
measure: Rate of Invasive and Non invasive mechanical ventilation
timeFrame: through study completion, an average of 4 year
Secondary outcomes:
measure: Frequency and type of Renal replacement therapies (RRT, dialysis)
timeFrame: through study completion, an average of 4 year
measure: Frequency of Blood transfusions
timeFrame: through study completion, an average of 4 year
measure: Frequency of ECMO Frequency of ECMO
timeFrame: through study completion, an average of 4 year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo
state: Lombardia
city: Rome
country: Italy
facility: University of Rome Tor Vergata
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)
city: Vilnius
country: Lithuania
facility: Vilnius universiteto ligoninė Santaros klinikos
city: Villahermosa
country: Mexico
facility: Regional Hospital Dr. Juan Graham Casasús, Villahermosa
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Poole
country: United Kingdom
facility: Poole University Hospitals, Dorset
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
Study officials:
affiliation: Karolinska Institutet
name: ANDERS Sönnerborg, Prof
role: STUDY_CHAIR
References: