Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05463380

Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

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

Primary outcomes

  1. Severity of SARS-CoV-2 infection

    Time frame: through study completion, an average of 4 year

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

  2. In-hospital mortality

    Time frame: through study completion, an average of 4 year

    YYYY-MM-DD or NA if discharged alive

  3. ICU Admissions and Discharges

    Time frame: through study completion, an average of 4 year

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

  4. Rate of Invasive and Non invasive mechanical ventilation

    Time frame: through study completion, an average of 4 year

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

Secondary outcomes

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

    Time frame: through study completion, an average of 4 year

    Yes/No/Unknown

  2. Frequency of Blood transfusions

    Time frame: through study completion, an average of 4 year

    Yes/No/Unknown

  3. Frequency of ECMO Frequency of ECMO

    Time frame: through study completion, an average of 4 year

    Yes/No/Unknown

Study contacts

Contact information is provided by the study sponsor or research team.

FRANCESCA INCARDONA Project Coordinator

CONTACT

[email protected]

+393356112830

Sponsors and collaborators

Lead sponsor

Euresist Network GEIE

Other

Collaborators

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

Registry information

Acronym: EuCARE-HOSP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.