Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Outpatient MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age and older willing and able to give informed consent to participate in the study 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: Symptoms of active respiratory viral infection: high temperature (over 37.8C/100.04F) cough (consistent for over an hour; 3 or more episodes in 24 hours) 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Outpatient MRI|Participation in the study includes up to 3 visits to a partnering imaging facility - this will include measurement of height and weight (to calculate BMI), blood pressure measurement, 3 sets of blood tests, 3 Questionnaires and 3 MRI tests. There will be no medical interventions as part of the study. All participants will receive standard-of-care by their healthcare provider/s. With the participant's consent, the participant's primary care physician will be made aware of their participation in the study. Furthermore, participants will be informed of any structural abnormalities found in the MRI scan (e.g. abnormal vessels, haemangioma, tumour, cyst, among others) and abnormal blood test results as these may have clinical implications.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver) | 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 | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen) | 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 | 12 Months | 
| Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star | 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) | 6 Months | 
| 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 | 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). | 12 Months | 
| Change in patient reported outcome measured by the Dyspnea-12 questionnaire | 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. | 12 Months | 
| Change in patient reported outcome measured by the Saint George's Respiratory questionnaire (SGRQ) | 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. | 12 Months | 
| Change in patient reported outcome measured by the EQ-5D-5L questionnaire | 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) | 12 Months | 
| Degree of change in liver MR-derived biomarkers | 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) | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, Obesity, Fatty Liver Disease