Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

NCT05463380 | Recruiting

• 1 other identifier: EuCARE-HOSPITALISED study
• Study Type: observational
• Target: 22,000
• Locations: 9 countries
• Sites: 10

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• Severity of SARS-CoV-2 infection

  This is currently being discussed, which classification system should be used. This will be harmonized to recommendations by the WHO/ISARIC or other source.

  through study completion, an average of 4 year

• In-hospital mortality

  YYYY-MM-DD or NA if discharged alive

  through study completion, an average of 4 year

• ICU Admissions and Discharges

  YYYY-MM-DD or NA if not ICU-admitted

  through study completion, an average of 4 year

• Rate of Invasive and Non invasive mechanical ventilation

  Yes/No/Unknown - If yes, duration of mechanical ventilation

  through study completion, an average of 4 year

Secondary Outcomes (3)

• Frequency and type of Renal replacement therapies (RRT, dialysis)

  through study completion, an average of 4 year

• Frequency of Blood transfusions

  through study completion, an average of 4 year

• Frequency of ECMO Frequency of ECMO

  through study completion, an average of 4 year

Study Arms (1)

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

Other: standard of care

Interventions

standard of care OTHER

The patient will be treated following the satndard of care in the participating units

Hospitalized COVID 19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Euresist Network GEIE: lead
• Karolinska Institutet: collaborator
• Centro Hospitalar Lisboa Ocidental: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• ASST Santi Paolo e Carlo: collaborator
• Imperial College London: collaborator
• Vilnius University Hospital Santaros Klinikos: collaborator
• University of Rome Tor Vergata: collaborator
• Bach Mai Hospital: collaborator
• Kenya Medical Research Institute: collaborator
• Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus": collaborator
• University Hospitals Dorset NHS Foundation Trust: collaborator

Study Sites (10)

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, Germany

RECRUITING

ASST Santi Paolo e Carlo

Milan, Lombardy, Italy

RECRUITING

University of Rome Tor Vergata

Rome, Italy

RECRUITING

Kenya Medical Research Institute (KEMRI)

Nairobi, Kenya

RECRUITING

Vilnius universiteto ligoninė Santaros klinikos

Vilnius, Lithuania

RECRUITING

Regional Hospital Dr. Juan Graham Casasús, Villahermosa

Villahermosa, Mexico

RECRUITING

Centro Hospitalar Lisboa Ocidental

Lisbon, Portugal

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

Poole University Hospitals, Dorset

Poole, United Kingdom

RECRUITING

Bach Mai Hospital

Hanoi, Vietnam

RECRUITING

Related Publications (1)

• 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.

  PMID: 37845624 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

biological material from COVID-19 in-patients in a diverse setting of 12 hospitals/clinics in 11 countries and 4 continents

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• ANDERS Sönnerborg, Prof

  Karolinska Institutet

  STUDY CHAIR

Central Study Contacts

FRANCESCA INCARDONA Project Coordinator

CONTACT

+393356112830; francesca.incardona@euresist.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: February 23, 2022
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: AFTER THE STUDY END NO TIME LIMIT WAS FIXED
• Access Criteria: REQUEST TO THE STUDY COORDINATOR OR TO THE PROJECT PARTNERS

Locations

LI (1); VN (1); DE (1); SE (1); PT (1); GB (1); KE (1); ME (1); IT (2)