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

Chahinda Ghossein-Doha; Marieke S.J.N. Wintjens; Emma B.N.J. Janssen; Dorthe Klein; Stella C.M. Heemskerk; Folkert W. Asselbergs; Erwin Birnie; Gouke J. Bonsel; Bas C.T. van Bussel; Jochen W.L. Cals; Hugo Ten Cate; Juanita Haagsma; Bena Hemmen; Iwan C.C. van der Horst; Bastiaan L.J.H. Kietselaer; Frederikus A. Klok; Martijn D. de Kruif; Marijke Linschoten; Susanne van Santen; Kevin Vernooy; Loes H. Willems; Rosa Westerborg; Michiel Warle; Sander M.J. van Kuijk

doi:10.1136/bmjopen-2022-065142

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

Chahinda Ghossein-Doha, Marieke S.J.N. Wintjens, Emma B.N.J. Janssen, Dorthe Klein, Stella C.M. Heemskerk, Folkert W. Asselbergs, Erwin Birnie, Gouke J. Bonsel, Bas C.T. van Bussel, Jochen W.L. Cals, Hugo Ten Cate, Juanita Haagsma, Bena Hemmen, Iwan C.C. van der Horst, Bastiaan L.J.H. Kietselaer, Frederikus A. Klok, Martijn D. de Kruif, Marijke Linschoten, Susanne van Santen, Kevin VernooyLoes H. Willems, Rosa Westerborg, Michiel Warle, Sander M.J. van Kuijk^*

^*Corresponding author for this work

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Abstract

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05240742.

Original language	English
Article number	e065142
Pages (from-to)	e065142
Journal	BMJ Open
Volume	12
Issue number	11
DOIs	https://doi.org/10.1136/bmjopen-2022-065142
Publication status	Published - 29 Nov 2022

Bibliographical note

Funding Information:
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.

Funding Information:
This work is supported by The Netherlands Organization for Health Research and Development (ZonMW), grant number 10430302110005, and an unrestricted grant has been received from the EuroQol Research Foundation. Individual COVID-19 cohorts contributing to the CORFU study may have been funded independently from this grant.

Publisher 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.

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Prevalence, pathophysiology, prediction and health-related quality of life of long COVID study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) studyFinal published version, 2.27 MBLicence: CC BY-NC

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Ghossein-Doha, C., Wintjens, M. S. J. N., Janssen, E. B. N. J., Klein, D., Heemskerk, S. C. M., Asselbergs, F. W., Birnie, E., Bonsel, G. J., van Bussel, B. C. T., Cals, J. W. L., Ten Cate, H., Haagsma, J., Hemmen, B., van der Horst, I. C. C., Kietselaer, B. L. J. H., Klok, F. A., de Kruif, M. D., Linschoten, M., van Santen, S., ... van Kuijk, S. M. J. (2022). Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study. BMJ Open, 12(11), e065142. Article e065142. https://doi.org/10.1136/bmjopen-2022-065142

@article{76759f2eb70746c9a91714bf08ec24ed,

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

abstract = "INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05240742.",

author = "Chahinda Ghossein-Doha and Wintjens, \{Marieke S.J.N.\} and Janssen, \{Emma B.N.J.\} and Dorthe Klein and Heemskerk, \{Stella C.M.\} and Asselbergs, \{Folkert W.\} and Erwin Birnie and Bonsel, \{Gouke J.\} and \{van Bussel\}, \{Bas C.T.\} and Cals, \{Jochen W.L.\} and \{Ten Cate\}, Hugo and Juanita Haagsma and Bena Hemmen and \{van der Horst\}, \{Iwan C.C.\} and Kietselaer, \{Bastiaan L.J.H.\} and Klok, \{Frederikus A.\} and \{de Kruif\}, \{Martijn D.\} and Marijke Linschoten and \{van Santen\}, Susanne and Kevin Vernooy and Willems, \{Loes H.\} and Rosa Westerborg and Michiel Warle and \{van Kuijk\}, \{Sander M.J.\}",

note = "Funding Information: 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. Funding Information: This work is supported by The Netherlands Organization for Health Research and Development (ZonMW), grant number 10430302110005, and an unrestricted grant has been received from the EuroQol Research Foundation. Individual COVID-19 cohorts contributing to the CORFU study may have been funded independently from this grant. Publisher Copyright: {\textcopyright} 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.",

year = "2022",

month = nov,

day = "29",

doi = "10.1136/bmjopen-2022-065142",

language = "English",

volume = "12",

pages = "e065142",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "11",

}

Ghossein-Doha, C, Wintjens, MSJN, Janssen, EBNJ, Klein, D, Heemskerk, SCM, Asselbergs, FW, Birnie, E, Bonsel, GJ, van Bussel, BCT, Cals, JWL, Ten Cate, H, Haagsma, J, Hemmen, B, van der Horst, ICC, Kietselaer, BLJH, Klok, FA, de Kruif, MD, Linschoten, M, van Santen, S, Vernooy, K, Willems, LH, Westerborg, R, Warle, M & van Kuijk, SMJ 2022, 'Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study', BMJ Open, vol. 12, no. 11, e065142, pp. e065142. https://doi.org/10.1136/bmjopen-2022-065142

Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study. / Ghossein-Doha, Chahinda; Wintjens, Marieke S.J.N.; Janssen, Emma B.N.J. et al.
In: BMJ Open, Vol. 12, No. 11, e065142, 29.11.2022, p. e065142.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Prevalence, pathophysiology, prediction and health-related quality of life of long COVID

T2 - study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study

AU - Ghossein-Doha, Chahinda

AU - Wintjens, Marieke S.J.N.

AU - Janssen, Emma B.N.J.

AU - Klein, Dorthe

AU - Heemskerk, Stella C.M.

AU - Asselbergs, Folkert W.

AU - Birnie, Erwin

AU - Bonsel, Gouke J.

AU - van Bussel, Bas C.T.

AU - Cals, Jochen W.L.

AU - Ten Cate, Hugo

AU - Haagsma, Juanita

AU - Hemmen, Bena

AU - van der Horst, Iwan C.C.

AU - Kietselaer, Bastiaan L.J.H.

AU - Klok, Frederikus A.

AU - de Kruif, Martijn D.

AU - Linschoten, Marijke

AU - van Santen, Susanne

AU - Vernooy, Kevin

AU - Willems, Loes H.

AU - Westerborg, Rosa

AU - Warle, Michiel

AU - van Kuijk, Sander M.J.

N1 - Funding Information: 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. Funding Information: This work is supported by The Netherlands Organization for Health Research and Development (ZonMW), grant number 10430302110005, and an unrestricted grant has been received from the EuroQol Research Foundation. Individual COVID-19 cohorts contributing to the CORFU study may have been funded independently from this grant. Publisher 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.

PY - 2022/11/29

Y1 - 2022/11/29

N2 - INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05240742.

AB - INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05240742.

UR - https://www.scopus.com/pages/publications/85143084516

U2 - 10.1136/bmjopen-2022-065142

DO - 10.1136/bmjopen-2022-065142

M3 - Article

C2 - 36446465

AN - SCOPUS:85143084516

SN - 2044-6055

VL - 12

SP - e065142

JO - BMJ Open

JF - BMJ Open

IS - 11

M1 - e065142

ER -

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

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