Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
NCT ID: NCT05463380
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
22000 participants
OBSERVATIONAL
2022-02-23
2026-10-13
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Hospitalized COVID 19 patients
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
standard of care
The patient will be treated following the satndard of care in the participating units
Interventions
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standard of care
The patient will be treated following the satndard of care in the participating units
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Centro Hospitalar Lisboa Ocidental
OTHER_GOV
Heinrich-Heine University, Duesseldorf
OTHER
ASST Santi Paolo e Carlo
OTHER
Imperial College London
OTHER
Vilnius University Hospital Santaros Klinikos
OTHER
University of Rome Tor Vergata
OTHER
Bach Mai Hospital
OTHER
Kenya Medical Research Institute
OTHER
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
OTHER
University Hospitals Dorset NHS Foundation Trust
OTHER_GOV
Euresist Network GEIE
OTHER
Responsible Party
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Principal Investigators
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ANDERS Sönnerborg, Prof
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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Heinrich-Heine-Universität Düsseldorf
Düsseldorf, , Germany
ASST Santi Paolo e Carlo
Milan, Lombardy, 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
Lisbon, , Portugal
Karolinska Institutet
Stockholm, , Sweden
Poole University Hospitals, Dorset
Poole, , United Kingdom
Bach Mai Hospital
Hanoi, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Björn-Erik O. Jensen, PROF
Role: primary
ANTONELLA D'ARMINIO MONFORTE, PROF
Role: primary
FRANCESCA CECCHERINI SILBERSTEIN
Role: primary
Matilu Mwau
Role: primary
DANIEL NAUMOVAS
Role: primary
Jesus Arturo Ruiz Quiñones
Role: primary
CRISTINA TOSCANO, PROF
Role: primary
ANDERS Sönnerborg, Prof
Role: primary
FRANCIS Drobniewski
Role: primary
Do Duy Cuong
Role: primary
References
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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: 10.1186/s12879-023-08658-2.
Other Identifiers
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EuCARE-HOSPITALISED study
Identifier Type: -
Identifier Source: org_study_id
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