Cargando…
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,...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1785121110700851200 |
---|---|
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. |
format | Online Article Text |
id | pubmed-10576381 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT variscobenedetta eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT baifrancesca eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT debenedittissara eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT tavellialessandro eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT cozzileprialessandro eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT salamatteo eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT miragliafedericagaia eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT santoromariamercedes eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT ceccherinisilbersteinfrancesca eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT shimoniyishai eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT ravidsivan eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT kozlovskital eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT konigflorian eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT pfeifernico eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT shamsaraelham eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT parczewskimilosz eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT monforteantonelladarminio eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT incardonafrancesca eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT mommochiara eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations AT marchettigiulia eucarepostcovidstudyamulticentrecohortstudyonlongtermpostcovid19manifestations |