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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>The trial has been registered on ClinicalTrials.gov. The unique identifier assigned to this trial is NCT05463380.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12879-023-08658-2","type":"journal-article","created":{"date-parts":[[2023,10,16]],"date-time":"2023-10-16T11:02:43Z","timestamp":1697454163000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["EuCARE-hospitalised study protocol: a cohort study of patients hospitalised with COVID-19 in the EuCARE project"],"prefix":"10.1186","volume":"23","author":[{"given":"Pontus","family":"Hedberg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedetta","family":"Varisco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Bai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"S\u00f6nnerborg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pontus","family":"Naucler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nico","family":"Pfeifer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Cozzi-Lepri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Ceccherini-Silberstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Naumovas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Drobniewski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f6rn-Erik Ole","family":"Jensen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Toscano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mi\u0142osz","family":"Parczewski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gibran Horemheb Rubio","family":"Quintanares","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matilu","family":"Mwau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge A.","family":"Pinto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Incardona","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Mommo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Marchetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,10,16]]},"reference":[{"key":"8658_CR1","unstructured":"ECDC. 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The study complies with the Declaration of Helsinki, GCP requirements, Human Subject Protection, and Data Protection Acts, or with the local law and regulation, whichever affords greater protection of human subjects.To safeguard the confidentiality of study participants, data are pseudonymised, and patients are provided with a unique patient identification (PID) number, which serves as the identification of the patient. The PID is assigned by the centre coordinator\/treating physician, who safely stores the de-coding list according to local regulations. Each patient has the same PID throughout the EuCARE project. If one patient is involved in different studies in different WPs of the EuCARE project, the centre coordinator\/treating physician holds the responsibility to ensure consistent use of the patients' PID across the various studies.Data sent to EuResist solely includes the PID number, and personal information from patient records are only released in accordance with the institutional Ethic Committee instructions on data release including the patient's written permission where required. Participants are informed about these conditions in any Informed Consent forms, when applicable. Before initiating of the study at each clinical research site, the protocol, all informed consent forms, and the participant information materials have been submitted to and approved by the following site's Ethics Committee: the Swedish Ethical Review Authority, Karolinska Institutet, Stockholm, Sweden; Comissao de Etica para a Saud\u00e8, Centro Hospitalar Lisboa Ocidental, Lisbon, Portugal; Ethic Committee at the Medical Faculty of the Heinrich-Heine University of Dusseldorf, D\u00fcsseldorf, Germany; Comitato Etico Milano Area 1, ASST Fatebenefratelli Sacco, ASST Santi Paolo e Carlo, Milan, Italy; NHS Health Research Authority \u2013 HRA and Health and Care Research Wales, Imperial College London, London, United Kingdom and University Hospital Dorset, Poole, United Kingdom; Vilniaus regioninins biomedicininiu tyrimu etikos komitetas, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania; Fondazione Policlinico Tor Vergata, Comitato Etico Indipendente, University of Rome Tor Vergata (UNITOV), Rome, Italy; Kenya Medical Research Institute and Ethics Review Unit, Nairobi, Kenya; Comit\u00e9 de Etica en Invest, Salud, Regional Hospital Dr. Juan Graham Casas\u00fas, Villahermosa, Mexico; Comissao de Etica IHMT \u2013 ITQB, Federal University of Minas Gerais, Minas Gerais, Brazil; Ethic Committee of Pomeranian Medical University Szczecin, Poland. The protocol has been submitted and the approval is ongoing at Bach Mai Hospital Bach Mai Hospital, Hanoi, Vietnam. Each enrolled subjects sign a written informed consent for study participation and personal data handling before enrolment.Furthermore, in the event of any future amendments to the study protocol, these changes will be submitted to and approved by each site's Ethics Committee. It is the responsibility of each participating site to ensure that all necessary documents and approvals are obtained in accordance with local\/national regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"690"}}