Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

NCT ID: NCT05463380

Last Updated: 2024-08-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

22000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-23

Study Completion Date

2026-10-13

Brief Summary

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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

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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

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Centro Hospitalar Lisboa Ocidental

OTHER_GOV

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

ASST Santi Paolo e Carlo

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role collaborator

University of Rome Tor Vergata

OTHER

Sponsor Role collaborator

Bach Mai Hospital

OTHER

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"

OTHER

Sponsor Role collaborator

University Hospitals Dorset NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Euresist Network GEIE

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

ASST Santi Paolo e Carlo

Milan, Lombardy, Italy

Site Status RECRUITING

University of Rome Tor Vergata

Rome, , Italy

Site Status RECRUITING

Kenya Medical Research Institute (KEMRI)

Nairobi, , Kenya

Site Status RECRUITING

Vilnius universiteto ligoninė Santaros klinikos

Vilnius, , Lithuania

Site Status RECRUITING

Regional Hospital Dr. Juan Graham Casasús, Villahermosa

Villahermosa, , Mexico

Site Status RECRUITING

Centro Hospitalar Lisboa Ocidental

Lisbon, , Portugal

Site Status RECRUITING

Karolinska Institutet

Stockholm, , Sweden

Site Status RECRUITING

Poole University Hospitals, Dorset

Poole, , United Kingdom

Site Status RECRUITING

Bach Mai Hospital

Hanoi, , Vietnam

Site Status RECRUITING

Countries

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Germany Italy Kenya Lithuania Mexico Portugal Sweden United Kingdom Vietnam

Central Contacts

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FRANCESCA INCARDONA Project Coordinator

Role: CONTACT

+393356112830

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.

Reference Type DERIVED
PMID: 37845624 (View on PubMed)

Other Identifiers

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EuCARE-HOSPITALISED study

Identifier Type: -

Identifier Source: org_study_id

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