NCT04369807

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 693 (actual)
• Sponsor: Perspectum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-21
• Primary completion: 2022-04-19
• Completion: 2022-04-19
• First posted: 2020-04-30
• Last updated: 2025-12-05

Locations

2 sites across 1 country: United Kingdom