Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Centro Hospitalar Lisboa Ocidental | OTHER_GOV |
| Heinrich-Heine University, Duesseldorf | OTHER |
| ASST Santi Paolo e Carlo |
Not provided
Not provided
Not provided
Not provided
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.
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:
Specific objectives are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care | Other | The patient will be treated following the satndard of care in the participating units |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria: none
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FRANCESCA INCARDONA Project Coordinator | Contact | +393356112830 | francesca.incardona@euresist.org |
| Name | Affiliation | Role |
|---|---|---|
| ANDERS Sönnerborg, Prof | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heinrich-Heine-Universität Düsseldorf | Recruiting | Düsseldorf | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37845624 | Derived | 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. |
Not provided
Not provided
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
AFTER THE STUDY END NO TIME LIMIT WAS FIXED
REQUEST TO THE STUDY COORDINATOR OR TO THE PROJECT PARTNERS
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| OTHER |
| Imperial College London | OTHER |
| Vilnius University Hospital Santaros Klinikos | OTHER |
| University of Rome Tor Vergata | OTHER |
| Bach Mai Hospital | OTHER |
| Kenya Medical Research Institute | OTHER |
| Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus" | OTHER |
| University Hospitals Dorset NHS Foundation Trust | OTHER_GOV |
Not provided
Not provided
Not provided
biological material from COVID-19 in-patients in a diverse setting of 12 hospitals/clinics in 11 countries and 4 continents
| 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 |
| ASST Santi Paolo e Carlo | Recruiting | Milan | Lombardy | Italy |
|
| University of Rome Tor Vergata | Recruiting | Rome | Italy |
|
| Kenya Medical Research Institute (KEMRI) | Recruiting | Nairobi | Kenya |
|
| Vilnius universiteto ligoninė Santaros klinikos | Recruiting | Vilnius | Lithuania |
|
| Regional Hospital Dr. Juan Graham Casasús, Villahermosa | Recruiting | Villahermosa | Mexico |
|
| Centro Hospitalar Lisboa Ocidental | Recruiting | Lisbon | Portugal |
|
| Karolinska Institutet | Recruiting | Stockholm | Sweden |
|
| Poole University Hospitals, Dorset | Recruiting | Poole | United Kingdom |
|
| Bach Mai Hospital | Recruiting | Hanoi | Vietnam |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |