COVERSCAN: Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection
Study Details
Study Description
Brief Summary
A prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
To date, correctly, all of the Government's efforts have been dedicated to providing sufficient hospital space, and the appropriate equipment, for treating the most serious cases of COVID-19. Equally, enormous resource is being dedicated to developing technologies that determine who has the disease, and who has developed antibodies to it.
However, patients recovering from serious disease will also pose a huge, ongoing challenge. Not only are people with co-morbidities including underlying fatty liver disease, metabolic syndrome and diabetes at higher risk for complications with COVID-19; but patients discharged from hospital after severe COVID-19 are reported to have liver and kidney injuries, and impacts on pancreas and spleen. However, the extent of organ health/damage has not been mapped.
This is a prospective, longitudinal, observational cohort study looking at patients recovering from COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury. This proposed study aims to measure the prevalence of organ volume changes and damage in lungs, heart, kidney, liver, pancreas, spleen as assessed by MRI among those having recovered, or recovering, from the SARS-CoV-2 infection - participants will have a final MRI scan at 12 months. Assessing the severity and sequelae of COVID-19 in patients is crucial to enable global planning for health-care needs. The study includes up to 3 visits for MRI scans and blood tests over a 12 month period. All participants will receive standard-of-care by their healthcare provider/s.
Study Design
Outcome Measures
Primary Outcome Measures
- Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver) [12 Months]
In patients recovering from COVID-19 disease: Characterise using summary statistics the prevalence and severity of organ volume change and damage to heart, kidneys and liver
Secondary Outcome Measures
- Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen) [12 Months]
In patients recovering from COVID-19 disease: To characterise using summary statistics the prevalence and severity of organ volume change and damage in lung, pancreas and spleen
- Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star [6 Months]
In patients recovering from COVID-19 disease: Characterise liver damage as assessed by liver volume in liters, iron corrected T1 (cT1) in milliseconds, liver fat content as %, liver T2star in milliseconds (a correlate of liver iron content)
- Change from Baseline in organ-specific biomarkers characterising organ volume change in the heart and spleen along with organ volume and damage in the kidney, liver and pancreas assessed by volume, iron corrected T1 (cT1) and fat infiltration [12 Months]
In patients recovering from COVID-19 disease: Characterise heart and spleen damage as assessed by liver volume in liters as well as kidney, liver and pancreas damage as assessed by volume in liters, iron corrected T1 (cT1) in milliseconds, fat infiltration as %, T2star in milliseconds (a correlate of liver iron content).
- Change in patient reported outcome measured by the Dyspnea-12 questionnaire [12 Months]
In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by Dyspnea-12. Each question is assigned a value between: none, mild, moderate and severe and is used to assess breathing characteristics.
- Change in patient reported outcome measured by the Saint George's Respiratory questionnaire (SGRQ) [12 Months]
In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the St. George's Respiratory questionnaire. Each section comprises of questions in various formats allowing to assess which aspects of the illness cause the participant the most problems in daily life. There is no score on a scale to communicate the scale title.
- Change in patient reported outcome measured by the EQ-5D-5L questionnaire [12 Months]
In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the EQ-5D-5L questionnaire. Two main sections provide the opportunity to capture statements best describing a participant's daily health and a scale form 0 to 100 capturing self-reported health stats. (100 being the best health imaginable and vice versa)
- Degree of change in liver MR-derived biomarkers [12 Months]
In patients recovering from COVID-19 disease: Difference from Baseline in degree of change in liver MR-derived biomarkers with and without known genetic variants associated with liver disease (e.g., PNPLA3) using a paired t-test (or non-parametric alternative)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female 18 years of age and older willing and able to give informed consent to participate in the study
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Recent confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged 7 or more days from hospital).
Exclusion Criteria:
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Symptoms of active respiratory viral infection:
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high temperature (over 37.8C/100.04F)
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cough (consistent for over an hour; 3 or more episodes in 24 hours)
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The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to pregnancy, a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
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Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Healthcare | London | United Kingdom | W1B 1PT | |
| 2 | Gemini | Oxford | United Kingdom | OX4 2LL |
Sponsors and Collaborators
- Perspectum
Investigators
- Principal Investigator: Rajarshi Banerjee, MSc, DPhil, Honorary Consultant Physician, Oxford University NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- WHO. (2020, February 28). Report of the WHO-China Joint Mission on Coronavirus Disease (COVID-19).
- Parisinos CA, W. H. (2020). Genetic studies of magnetic resonance imaging of the liver implicate metal ion transporters in the pathogenesis of steatohepatitis in UK Biobank. J Hepatol
- COVID-19 Surveillance Group. (2020). Characteristics of COVID-19 patients dying in Italy: report based on available data on March 20th, 2020. : ; 2020. Rome, Italy: Instituto Superiore Di Sanita.
Publications
None provided.- 20/SC/0185