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EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations

BACKGROUND: Post-COVID-19 condition refers to persistent or new onset symptoms occurring three months after acute COVID-19, which are unrelated to alternative diagnoses. Symptoms include fatigue, breathlessness, palpitations, pain, concentration difficulties ("brain fog"), sleep disorders,...

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Autores principales: Varisco, Benedetta, Bai, Francesca, De Benedittis, Sara, Tavelli, Alessandro, Cozzi-Lepri, Alessandro, Sala, Matteo, Miraglia, Federica Gaia, Santoro, Maria Mercedes, Ceccherini-Silberstein, Francesca, Shimoni, Yishai, Ravid, Sivan, Kozlovski, Tal, König, Florian, Pfeifer, Nico, Shamsara, Elham, Parczewski, Milosz, Monforte, Antonella d’Arminio, Incardona, Francesca, Mommo, Chiara, Marchetti, Giulia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10576381/
https://www.ncbi.nlm.nih.gov/pubmed/37833640
http://dx.doi.org/10.1186/s12879-023-08595-0
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author Varisco, Benedetta
Bai, Francesca
De Benedittis, Sara
Tavelli, Alessandro
Cozzi-Lepri, Alessandro
Sala, Matteo
Miraglia, Federica Gaia
Santoro, Maria Mercedes
Ceccherini-Silberstein, Francesca
Shimoni, Yishai
Ravid, Sivan
Kozlovski, Tal
König, Florian
Pfeifer, Nico
Shamsara, Elham
Parczewski, Milosz
Monforte, Antonella d’Arminio
Incardona, Francesca
Mommo, Chiara
Marchetti, Giulia
author_facet Varisco, Benedetta
Bai, Francesca
De Benedittis, Sara
Tavelli, Alessandro
Cozzi-Lepri, Alessandro
Sala, Matteo
Miraglia, Federica Gaia
Santoro, Maria Mercedes
Ceccherini-Silberstein, Francesca
Shimoni, Yishai
Ravid, Sivan
Kozlovski, Tal
König, Florian
Pfeifer, Nico
Shamsara, Elham
Parczewski, Milosz
Monforte, Antonella d’Arminio
Incardona, Francesca
Mommo, Chiara
Marchetti, Giulia
author_sort Varisco, Benedetta
collection PubMed
description BACKGROUND: Post-COVID-19 condition refers to persistent or new onset symptoms occurring three months after acute COVID-19, which are unrelated to alternative diagnoses. Symptoms include fatigue, breathlessness, palpitations, pain, concentration difficulties ("brain fog"), sleep disorders, and anxiety/depression. The prevalence of post-COVID-19 condition ranges widely across studies, affecting 10–20% of patients and reaching 50–60% in certain cohorts, while the associated risk factors remain poorly understood. METHODS: This multicentre cohort study, both retrospective and prospective, aims to assess the incidence and risk factors of post-COVID-19 condition in a cohort of recovered patients. Secondary objectives include evaluating the association between circulating SARS-CoV-2 variants and the risk of post-COVID-19 condition, as well as assessing long-term residual organ damage (lung, heart, central nervous system, peripheral nervous system) in relation to patient characteristics and virology (variant and viral load during the acute phase). Participants will include hospitalised and outpatient COVID-19 patients diagnosed between 01/03/2020 and 01/02/2025 from 8 participating centres. A control group will consist of hospitalised patients with respiratory infections other than COVID-19 during the same period. Patients will be followed up at the post-COVID-19 clinic of each centre at 2–3, 6–9, and 12–15 months after clinical recovery. Routine blood exams will be conducted, and patients will complete questionnaires to assess persisting symptoms, fatigue, dyspnoea, quality of life, disability, anxiety and depression, and post-traumatic stress disorders. DISCUSSION: This study aims to understand post-COVID-19 syndrome's incidence and predictors by comparing pandemic waves, utilising retrospective and prospective data. Gender association, especially the potential higher prevalence in females, will be investigated. Symptom tracking via questionnaires and scales will monitor duration and evolution. Questionnaires will also collect data on vaccination, reinfections, and new health issues. Biological samples will enable future studies on post-COVID-19 sequelae mechanisms, including inflammation, immune dysregulation, and viral reservoirs. TRIAL REGISTRATION: This study has been registered with ClinicalTrials.gov under the identifier NCT05531773. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-023-08595-0.
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spelling pubmed-105763812023-10-15 EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations Varisco, Benedetta Bai, Francesca De Benedittis, Sara Tavelli, Alessandro Cozzi-Lepri, Alessandro Sala, Matteo Miraglia, Federica Gaia Santoro, Maria Mercedes Ceccherini-Silberstein, Francesca Shimoni, Yishai Ravid, Sivan Kozlovski, Tal König, Florian Pfeifer, Nico Shamsara, Elham Parczewski, Milosz Monforte, Antonella d’Arminio Incardona, Francesca Mommo, Chiara Marchetti, Giulia BMC Infect Dis Study Protocol BACKGROUND: Post-COVID-19 condition refers to persistent or new onset symptoms occurring three months after acute COVID-19, which are unrelated to alternative diagnoses. Symptoms include fatigue, breathlessness, palpitations, pain, concentration difficulties ("brain fog"), sleep disorders, and anxiety/depression. The prevalence of post-COVID-19 condition ranges widely across studies, affecting 10–20% of patients and reaching 50–60% in certain cohorts, while the associated risk factors remain poorly understood. METHODS: This multicentre cohort study, both retrospective and prospective, aims to assess the incidence and risk factors of post-COVID-19 condition in a cohort of recovered patients. Secondary objectives include evaluating the association between circulating SARS-CoV-2 variants and the risk of post-COVID-19 condition, as well as assessing long-term residual organ damage (lung, heart, central nervous system, peripheral nervous system) in relation to patient characteristics and virology (variant and viral load during the acute phase). Participants will include hospitalised and outpatient COVID-19 patients diagnosed between 01/03/2020 and 01/02/2025 from 8 participating centres. A control group will consist of hospitalised patients with respiratory infections other than COVID-19 during the same period. Patients will be followed up at the post-COVID-19 clinic of each centre at 2–3, 6–9, and 12–15 months after clinical recovery. Routine blood exams will be conducted, and patients will complete questionnaires to assess persisting symptoms, fatigue, dyspnoea, quality of life, disability, anxiety and depression, and post-traumatic stress disorders. DISCUSSION: This study aims to understand post-COVID-19 syndrome's incidence and predictors by comparing pandemic waves, utilising retrospective and prospective data. Gender association, especially the potential higher prevalence in females, will be investigated. Symptom tracking via questionnaires and scales will monitor duration and evolution. Questionnaires will also collect data on vaccination, reinfections, and new health issues. Biological samples will enable future studies on post-COVID-19 sequelae mechanisms, including inflammation, immune dysregulation, and viral reservoirs. TRIAL REGISTRATION: This study has been registered with ClinicalTrials.gov under the identifier NCT05531773. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-023-08595-0. BioMed Central 2023-10-13 /pmc/articles/PMC10576381/ /pubmed/37833640 http://dx.doi.org/10.1186/s12879-023-08595-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Varisco, Benedetta
Bai, Francesca
De Benedittis, Sara
Tavelli, Alessandro
Cozzi-Lepri, Alessandro
Sala, Matteo
Miraglia, Federica Gaia
Santoro, Maria Mercedes
Ceccherini-Silberstein, Francesca
Shimoni, Yishai
Ravid, Sivan
Kozlovski, Tal
König, Florian
Pfeifer, Nico
Shamsara, Elham
Parczewski, Milosz
Monforte, Antonella d’Arminio
Incardona, Francesca
Mommo, Chiara
Marchetti, Giulia
EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
title EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
title_full EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
title_fullStr EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
title_full_unstemmed EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
title_short EuCARE-POSTCOVID Study: a multicentre cohort study on long-term post-COVID-19 manifestations
title_sort eucare-postcovid study: a multicentre cohort study on long-term post-covid-19 manifestations
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10576381/
https://www.ncbi.nlm.nih.gov/pubmed/37833640
http://dx.doi.org/10.1186/s12879-023-08595-0
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