Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

COVID-19 Clinical Trial

— EuCARE-HOSP  

Official title:

Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463380
• Other study ID #: EuCARE-HOSPITALISED study
• Status: Recruiting
• Start date: February 23, 2022
• Est. completion date: October 13, 2026

Study information

• Verified date: July 2023
• Source: Euresist Network GEIE
• Contact: FRANCESCA INCARDONA Project Coordinator
• Phone: +393356112830
• Email: francesca.incardona[@]euresist.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22000
• Est. completion date: October 13, 2026
• Est. primary completion date: October 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• standard of care
The patient will be treated following the satndard of care in the participating units

Locations

Country	Name	City	State
Germany	Heinrich-Heine-Universität Düsseldorf	Düsseldorf
Italy	ASST Santi Paolo e Carlo	Milan	Lombardia
Italy	University of Rome Tor Vergata	Rome
Kenya	Kenya Medical Research Institute (KEMRI)	Nairobi
Lithuania	Vilnius universiteto ligonine Santaros klinikos	Vilnius
Mexico	Regional Hospital Dr. Juan Graham Casasús, Villahermosa	Villahermosa
Portugal	Centro Hospitalar Lisboa Ocidental	Lisboa
Sweden	Karolinska Institutet	Stockholm
United Kingdom	Poole University Hospitals, Dorset	Poole
Vietnam	Bach Mai Hospital	Hanoi

Sponsors (12)

Lead Sponsor	Collaborator
Euresist Network GEIE	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

Countries where clinical trial is conducted

Germany,  Italy,  Kenya,  Lithuania,  Mexico,  Portugal,  Sweden,  United Kingdom,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	In-hospital mortality	YYYY-MM-DD or NA if discharged alive	through study completion, an average of 4 year
Primary	ICU Admissions and Discharges	YYYY-MM-DD or NA if not ICU-admitted	through study completion, an average of 4 year
Primary	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	Frequency and type of Renal replacement therapies (RRT, dialysis)	Yes/No/Unknown	through study completion, an average of 4 year
Secondary	Frequency of Blood transfusions	Yes/No/Unknown	through study completion, an average of 4 year
Secondary	Frequency of ECMO Frequency of ECMO	Yes/No/Unknown	through study completion, an average of 4 year