EuCARE-hospitalised study protocol: a cohort study of patients hospitalised with COVID-19 in the EuCARE project

• Published in: BMC infectious diseases 2023-10, Vol.23 (1), p.1-690, Article 690
• Main Authors: Hedberg, Pontus, Varisco, Benedetta, Bai, Francesca, Sönnerborg, Anders, Naucler, Pontus, Pfeifer, Nico, Cozzi-Lepri, Alessandro, Ceccherini-Silberstein, Francesca, Naumovas, Daniel, Drobniewski, Francis, Jensen, Björn-Erik Ole, Toscano, Cristina, Parczewski, MiÅosz, Quintanares, Gibran Horemheb Rubio, Mwau, Matilu, Pinto, Jorge A, Incardona, Francesca, Mommo, Chiara, Marchetti, Giulia
• Format: Article
• Language: English
• Subjects: Analysis; Biological materials; Biological properties; Biological samples; Clinical outcomes; Cohort analysis; Coronaviruses; COVID-19; COVID-19 vaccines; Data analysis; Data collection; Data entry; Effectiveness; Evaluation; General Data Protection Regulation; Health aspects; Hospital patients; Hospitalised COVID-19 patients; COVID-19 mortality; SARS-CoV-2 variants; SARS-CoV-2 vaccination and immunity; Hospitalization; Hospitals; Immune response; Infections; Information management; Machine learning; Medical personnel; Medical research; Medicin och hälsovetenskap; Medicine, Experimental; Mortality; Pandemics; Patients; Respiratory diseases; Risk factors; Schools; Severe acute respiratory syndrome coronavirus 2; Study Protocol; Therapeutic applications; Vaccination; Vaccine efficacy; Vaccines; Ventilators; Viral diseases
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/s12879-023-08658-2

Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), can lead to hospitalisation, particularly in elderly, immunocompromised, and non-vaccinated or partially vaccinated individuals. Although vaccination provides protection, the duration of this protection wanes over time. Additional doses can restore immunity, but the influence of viral variants, specific sequences, and vaccine-induced immune responses on disease severity remains unclear. Moreover, the efficacy of therapeutic interventions during hospitalisation requires further investigation. The study aims to analyse the clinical course of COVID-19 in hospitalised patients, taking into account SARS-CoV-2 variants, viral sequences, and the impact of different vaccines. The primary outcome is all-cause in-hospital mortality, while secondary outcomes include admission to intensive care unit and length of stay, duration of hospitalisation, and the level of respiratory support required. This ongoing multicentre study observes hospitalised adult patients with confirmed SARS-CoV-2 infection, utilising a combination of retrospective and prospective data collection. It aims to gather clinical and laboratory variables from around 35,000 patients, with potential for a larger sample size. Data analysis will involve biostatistical and machine-learning techniques. Selected patients will provide biological material. The study started on October 14, 2021 and is scheduled to end on October 13, 2026. The analysis of a large sample of retrospective and prospective data about the acute phase of SARS CoV-2 infection in hospitalised patients, viral variants and vaccination in several European and non-European countries will help us to better understand risk factors for disease severity and the interplay between SARS CoV-2 variants, immune responses and vaccine efficacy. The main strengths of this study are the large sample size, the long study duration covering different waves of COVID-19 and the collection of biological samples that allows future research.