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

Completed

• Conditions: COVID-19

• Registration Number: NCT04369807
• Lead Sponsor: Perspectum

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.

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 Timeline

• Study Start: 2020-04-21
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Status Verified: 2022-01
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (2)

Gemini; 🇬🇧 Oxford, United Kingdom

Mayo Clinic Healthcare; 🇬🇧 London, United Kingdom