Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls
Introduction SARS-CoV-2 disease (COVID-19) has had an enormous health and economic impact globally. Although primarily a respiratory illness, multi-organ involvement is common in COVID-19, with evidence of vascular-mediated damage in the heart, liver, kidneys and brain in a substantial proportion of...
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BMJ Publishing Group
2025-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/3/e089508.full |
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| author | Christopher E Brightling Kamlesh Khunti Naveed Sattar Colin Berry John P Greenwood Gerry P McCann Kelly S Parke Joanne V Wormleighton Stefan Neubauer Betty Raman Charalambos Antoniades Elizabeth M Tunnicliffe Alastair Moss Jayanth Ranjit Arnold Mark Toshner Sue Francis Sandeep S Hothi Stephen M Smith Mohamed Elshibly Simran Shergill Rachel J England George J Hudson James Wild |
| author_facet | Christopher E Brightling Kamlesh Khunti Naveed Sattar Colin Berry John P Greenwood Gerry P McCann Kelly S Parke Joanne V Wormleighton Stefan Neubauer Betty Raman Charalambos Antoniades Elizabeth M Tunnicliffe Alastair Moss Jayanth Ranjit Arnold Mark Toshner Sue Francis Sandeep S Hothi Stephen M Smith Mohamed Elshibly Simran Shergill Rachel J England George J Hudson James Wild |
| author_sort | Christopher E Brightling |
| collection | DOAJ |
| description | Introduction SARS-CoV-2 disease (COVID-19) has had an enormous health and economic impact globally. Although primarily a respiratory illness, multi-organ involvement is common in COVID-19, with evidence of vascular-mediated damage in the heart, liver, kidneys and brain in a substantial proportion of patients following moderate-to-severe infection. The pathophysiology and long-term clinical implications of multi-organ injury remain to be fully elucidated. Age, gender, ethnicity, frailty and deprivation are key determinants of infection severity, and both morbidity and mortality appear higher in patients with underlying comorbidities such as ischaemic heart disease, hypertension and diabetes. Our aim is to gain mechanistic insights into the pathophysiology of multiorgan dysfunction in people with COVID-19 and maximise the impact of national COVID-19 studies with a comparison group of COVID-negative controls.Methods and analysis COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19 (COSMIC) is a prospective, multicentre UK study which will recruit 200 subjects without clinical evidence of prior COVID-19 and perform extensive phenotyping with multiorgan imaging, biobank serum storage, functional assessment and patient reported outcome measures, providing a robust control population to facilitate current work and serve as an invaluable bioresource for future observational studies.Ethics and dissemination Approved by the National Research Ethics Service Committee East Midlands (REC reference 19/EM/0295). Results will be disseminated via peer-reviewed journals and scientific meetings.Trial registration number COSMIC is registered as an extension of C-MORE (Capturing Multi-ORgan Effects of COVID-19) on ClinicalTrials.gov (NCT04510025). |
| format | Article |
| id | doaj-art-8845cd9c1f8d4f39883ca4f3e4cb3cc5 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8845cd9c1f8d4f39883ca4f3e4cb3cc52025-08-20T02:58:21ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-089508Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controlsChristopher E Brightling0Kamlesh Khunti1Naveed Sattar2Colin Berry3John P Greenwood4Gerry P McCann5Kelly S Parke6Joanne V Wormleighton7Stefan Neubauer8Betty Raman9Charalambos Antoniades10Elizabeth M Tunnicliffe11Alastair Moss12Jayanth Ranjit Arnold13Mark Toshner14Sue Francis15Sandeep S Hothi16Stephen M Smith17Mohamed Elshibly18Simran Shergill19Rachel J England20George J Hudson21James Wild2215 Infection, Inflammation and Immunity, University of Leicester, Leicester, UK13 Diabetes Research Centre, University of Leicester, Leicester, UK12 Institute of Cardiovascular and Medical Sciences and British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK12 Institute of Cardiovascular and Medical Sciences and British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK16 Baker Heart and Diabetes Institute South Australia, Melbourne, Victoria, Australia1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK5 Division of Cardiovascular Medicine, Radcliffe Department of Medicine, Oxford Centre for Clinical Magnetic Resonance Research, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, University of Oxford, Oxford, UK5 Division of Cardiovascular Medicine, Radcliffe Department of Medicine, Oxford Centre for Clinical Magnetic Resonance Research, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, University of Oxford, Oxford, UK5 Division of Cardiovascular Medicine, Radcliffe Department of Medicine, Oxford Centre for Clinical Magnetic Resonance Research, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, University of Oxford, Oxford, UK5 Division of Cardiovascular Medicine, Radcliffe Department of Medicine, Oxford Centre for Clinical Magnetic Resonance Research, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, University of Oxford, Oxford, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK11 National Institute for Health Research Cambridge Clinical Research Facility and Biomedical Research Centre, University of Cambridge, Cambridge, UK9 Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, UK2 Department of Cardiology, Heart and Lung Centre, Royal Wolverhampton NHS Trust, Wolverhampton, UK8 Oxford Centre for Functional MRI of the Brain, Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK1 Department of Cardiovascular Sciences and the National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, University of Leicester, Leicester, UK6 POLARIS Imaging Group, The Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Faculty of Medicine Dentistry and Health, Sheffield, UKIntroduction SARS-CoV-2 disease (COVID-19) has had an enormous health and economic impact globally. Although primarily a respiratory illness, multi-organ involvement is common in COVID-19, with evidence of vascular-mediated damage in the heart, liver, kidneys and brain in a substantial proportion of patients following moderate-to-severe infection. The pathophysiology and long-term clinical implications of multi-organ injury remain to be fully elucidated. Age, gender, ethnicity, frailty and deprivation are key determinants of infection severity, and both morbidity and mortality appear higher in patients with underlying comorbidities such as ischaemic heart disease, hypertension and diabetes. Our aim is to gain mechanistic insights into the pathophysiology of multiorgan dysfunction in people with COVID-19 and maximise the impact of national COVID-19 studies with a comparison group of COVID-negative controls.Methods and analysis COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19 (COSMIC) is a prospective, multicentre UK study which will recruit 200 subjects without clinical evidence of prior COVID-19 and perform extensive phenotyping with multiorgan imaging, biobank serum storage, functional assessment and patient reported outcome measures, providing a robust control population to facilitate current work and serve as an invaluable bioresource for future observational studies.Ethics and dissemination Approved by the National Research Ethics Service Committee East Midlands (REC reference 19/EM/0295). Results will be disseminated via peer-reviewed journals and scientific meetings.Trial registration number COSMIC is registered as an extension of C-MORE (Capturing Multi-ORgan Effects of COVID-19) on ClinicalTrials.gov (NCT04510025).https://bmjopen.bmj.com/content/15/3/e089508.full |
| spellingShingle | Christopher E Brightling Kamlesh Khunti Naveed Sattar Colin Berry John P Greenwood Gerry P McCann Kelly S Parke Joanne V Wormleighton Stefan Neubauer Betty Raman Charalambos Antoniades Elizabeth M Tunnicliffe Alastair Moss Jayanth Ranjit Arnold Mark Toshner Sue Francis Sandeep S Hothi Stephen M Smith Mohamed Elshibly Simran Shergill Rachel J England George J Hudson James Wild Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls BMJ Open |
| title | Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls |
| title_full | Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls |
| title_fullStr | Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls |
| title_full_unstemmed | Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls |
| title_short | Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls |
| title_sort | assessing the impact of comorbidities and sociodemographic factors on multiorgan injury following covid 19 rationale and protocol design of cosmic a uk multicentre observational study of covid negative controls |
| url | https://bmjopen.bmj.com/content/15/3/e089508.full |
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