Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project (EuCARE-HOSP)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: standard of care

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

• Study Type: Observational
• Enrollment (Estimated): 22000

Contacts and Locations

• Study Contact: Name: FRANCESCA INCARDONA Project Coordinator; Phone Number: +393356112830; Email: francesca.incardona@euresist.org

Study Locations

• Germany
  • Düsseldorf, Germany
    • Recruiting
    • Heinrich-Heine-Universität Düsseldorf
    • Contact: Björn-Erik O. Jensen, PROF
• Italy
  • Rome, Italy
    • Recruiting
    • University of Rome Tor Vergata
    • Contact: FRANCESCA CECCHERINI SILBERSTEIN
  • Lombardia
    • Milan, Lombardia, Italy
      • Recruiting
      • ASST Santi Paolo e Carlo
      • Contact: ANTONELLA D'ARMINIO MONFORTE, PROF
• Kenya
  • Nairobi, Kenya
    • Recruiting
    • Kenya Medical Research Institute (KEMRI)
    • Contact: Matilu Mwau
• Lithuania
  • Vilnius, Lithuania
    • Recruiting
    • Vilnius universiteto ligoninė Santaros klinikos
    • Contact: DANIEL NAUMOVAS
• Mexico
  • Villahermosa, Mexico
    • Recruiting
    • Regional Hospital Dr. Juan Graham Casasús, Villahermosa
    • Contact: Jesus Arturo Ruiz Quiñones
• Portugal
  • Lisboa, Portugal
    • Recruiting
    • Centro Hospitalar Lisboa Ocidental
    • Contact: CRISTINA TOSCANO, PROF
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institutet
    • Contact: ANDERS Sönnerborg, Prof
    • Principal Investigator: Anders Sönnerborg, Prof
• United Kingdom
  • Poole, United Kingdom
    • Recruiting
    • Poole University Hospitals, Dorset
    • Contact: FRANCIS Drobniewski
• Vietnam
  • Hanoi, Vietnam
    • Recruiting
    • Bach Mai Hospital
    • Contact: Do Duy Cuong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The patient will be treated following the satndard of care in the participating units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and type of Renal replacement therapies (RRT, dialysis)	Yes/No/Unknown	through study completion, an average of 4 year
Frequency of Blood transfusions	Yes/No/Unknown	through study completion, an average of 4 year
Frequency of ECMO Frequency of ECMO	Yes/No/Unknown	through study completion, an average of 4 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EuCARE-HOSPITALISED study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study is part of a project funded by the European Commission and the project agreement with the Commission affirms that the data and the results will be publi
• IPD Sharing Time Frame: AFTER THE STUDY END NO TIME LIMIT WAS FIXED
• IPD Sharing Access Criteria: REQUEST TO THE STUDY COORDINATOR OR TO THE PROJECT PARTNERS
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No