Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
29 11 2022
Historique:
entrez: 29 11 2022
pubmed: 30 11 2022
medline: 2 12 2022
Statut: epublish

Résumé

The variety, time patterns and long-term prognosis of persistent COVID-19 symptoms (long COVID-19) in patients who suffered from mild to severe acute COVID-19 are incompletely understood. Cohort studies will be combined to describe the prevalence of long COVID-19 symptoms, and to explore the pathophysiological mechanisms and impact on health-related quality of life. A prediction model for long COVID-19 will be developed and internally validated to guide care in future patients. Data from seven COVID-19 cohorts will be aggregated in the longitudinal multiple cohort CORona Follow Up (CORFU) study. CORFU includes Dutch patients who suffered from COVID-19 at home, were hospitalised without or with intensive care unit treatment, needed inpatient or outpatient rehabilitation and controls who did not suffer from COVID-19. Individual cohort study designs were aligned and follow-up has been synchronised. Cohort participants will be followed up for a maximum of 24 months after acute infection. Next to the clinical characteristics measured in individual cohorts, the CORFU questionnaire on long COVID-19 outcomes and determinants will be administered digitally at 3, 6, 12, 18 and 24 months after the infection. The primary outcome is the prevalence of long COVID-19 symptoms up to 2 years after acute infection. Secondary outcomes are health-related quality of life (eg, EQ-5D), physical functioning, and the prevalence of thromboembolic complications, respiratory complications, cardiovascular diseases and endothelial dysfunction. A prediction model and a patient platform prototype will be developed. Approval was obtained from the medical research ethics committee of Maastricht University Medical Center+ and Maastricht University (METC 2021-2990) and local committees of the participating cohorts. The project is supported by ZonMW and EuroQol Research Foundation. Results will be published in open access peer-reviewed scientific journals and presented at (inter)national conferences. NCT05240742.

Identifiants

pubmed: 36446465
pii: bmjopen-2022-065142
doi: 10.1136/bmjopen-2022-065142
pmc: PMC9709810
doi:

Banques de données

ClinicalTrials.gov
['NCT05240742']

Types de publication

Clinical Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e065142

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: BCTvB, BH, BLJHK, JH, DK, EB, EBNJJ, GJB, ICCvdH, JH, JWLC, LHW, MSJNW, MW, RW, SCMH, SMJK, SvS and BH declare no competing interests. FAK received research support from Bayer, BMS, Boehringer-Ingelheim, MSD, Daiichi-Sankyo, Actelion, Boston Scientific, The Netherlands Organization for Health Research and Development (ZonMW), The Dutch Thrombosis Association, and The Dutch Heart Foundation. FWA is supported by the National Institute of Health Research University College London Hospitals Biomedical Research Centre. For the CAPACITY-COVID cohort participating in CORFU, FWA and ML received support from Dutch Heart Foundation (2020B006 CAPACITY) an The Netherlands Organization for Health Research and Development (ZonMW) (grant number 10430102110006 DEFENCE). HTC received support from Bayer, received consulting fees from Pfizer, Leo, Alveron, Viatris, Astra Zeneca, and Galapagos, and has stock (options) in Coagulation Profile. KV has royalities or licences for Philips, Medtronic, Abbott, and Biosense Webster, received consulting fees from Philips, Biosense Webster, Boston Scientific, and Medtronic, and has a role in the European Heart Rhythm Association congress organization and digital committee. MDdK received a presentation fee from Glaxo Smith Kline. ML is supported by the Alexandre Suerman Stipend of the University Medical Center Utrecht.

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Auteurs

Chahinda Ghossein-Doha (C)

Department of Cardiology, Maastricht UMC+, Maastricht, The Netherlands.
Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.

Marieke S J N Wintjens (MSJN)

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht UMC+, Maastricht, The Netherlands.
Intensive Care Medicine, Maastricht UMC+, Maastricht, The Netherlands.

Emma B N J Janssen (EBNJ)

Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.
Department of Obstetrics and Gynaecology, Maastricht UMC+, Maastricht, The Netherlands.

Dorthe Klein (D)

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht UMC+, Maastricht, The Netherlands.
Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

Stella C M Heemskerk (SCM)

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht UMC+, Maastricht, The Netherlands.
Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

Folkert W Asselbergs (FW)

Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Institute of Cardiovascular Science, Faculty of Population Health Sciences, Health Data Research UK and Institute of Health Informatics, University College London, London, UK.

Erwin Birnie (E)

Scientific Department, EuroQol Research Foundation, Rotterdam, The Netherlands.
Department of Genetics, University Medical Centre Groningen, Groningen, The Netherlands.

Gouke J Bonsel (GJ)

Scientific Department, EuroQol Research Foundation, Rotterdam, The Netherlands.

Bas C T van Bussel (BCT)

Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Department of Intensive Care, Maastricht UMC+, Maastricht, The Netherlands.

Jochen W L Cals (JWL)

Department of Family Medicine, Maastricht University, Maastricht, The Netherlands.
Care and Public Health Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

Hugo Ten Cate (H)

Department of Biochemistry, Department of Internal Medicine, Thrombosis Expert Centre, Maastricht, The Netherlands.
Department of Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.

Juanita Haagsma (J)

Department of Public Health, Erasmus MC, Rotterdam, The Netherlands.

Bena Hemmen (B)

Care and Public Health Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Department of Rehabilitation Medicine, Functioning, Participation & Rehabilitation, Maastricht University, Maastricht, The Netherlands.

Iwan C C van der Horst (ICC)

Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.
Department of Intensive Care, Maastricht University Medical Centre+, Maastricht, The Netherlands.

Bastiaan L J H Kietselaer (BLJH)

Department of Cardiology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands.
Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota, USA.

Frederikus A Klok (FA)

Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.

Martijn D de Kruif (MD)

Department of Pulmonology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands.

Marijke Linschoten (M)

Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Netherlands Heart Institute, Utrecht, The Netherlands.

Susanne van Santen (S)

Department of Intensive Care, Maastricht UMC+, Maastricht, The Netherlands.
Care and Public Health Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

Kevin Vernooy (K)

Department of Cardiology, Maastricht UMC+, Maastricht, The Netherlands.
Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.

Loes H Willems (LH)

Department of Surgery, Radboudumc Radboud Institute for Health Sciences, Nijmegen, The Netherlands.

Rosa Westerborg (R)

Department of Pulmonology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands.

Michiel Warle (M)

Department of Surgery, Radboudumc Radboud Institute for Health Sciences, Nijmegen, The Netherlands.

Sander M J van Kuijk (SMJ)

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht UMC+, Maastricht, The Netherlands sander.van.kuijk@mumc.nl.
Care and Public Health Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

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