Oxford, U.K.-based Perspectum Diagnostics Ltd. is recruiting patients for a study to determine the degree of damage sustained by major organs following infection with the SARS-CoV-2 virus. The company will use its multiparametric magnetic resonance imaging (MRI) devices and other means to evaluate post-COVID-19 organ damage, track healing and evaluate impact on survivors.
“We lack comprehensive knowledge of the medium- to long-term effect of SARS-CoV-2 infection on organ health. Initial reports suggest, however, that there is evidence of organ damage in those being discharged following severe COVID-19 disease,” said Mary Xu, head of clinical affairs at Perspectum.
With more than 2.7 million people globally already diagnosed with COVID-19 and nearly 750,000 survivors to date, better understanding of the long-term ramifications of the disease on patients and health care systems is needed urgently.
“We will look at the heart, kidneys, liver, lungs, pancreas and spleen,” Carlos Duncker, Perspectum’s medical science liaison and study investigator, told BioWorld. “We will be measuring (differing for each organ) organ volume, fat infiltration, scarring and inflammation. We will also be assessing these measures and [comparing them] with known genetic variants of disease. Finally, we will be collecting information on breathlessness and its effect on overall health and daily life via online questionnaires.”
The goal is to track how the virus affects the body over the long term.
“Through this study, we want to gain a better understanding of the impact of this disease by mapping the extent of organ health. In doing so, we hope to further support global efforts in planning for ongoing health care needs. The Coverscan study has been designed to safely assess patients, using noninvasive imaging, with minimal risk to all involved,” Xu explained.
The Coverscan study aims to enroll 507 patients over the next two years at the Mayo Clinic in London and at the company’s outpatient facility in Oxford, U.K. “The study recruitment is open, and we will begin seeing patients next week,” Jasmin Hounsell, Perspectum’s head of marketing, told BioWorld.
“To maximize patient safety, we will run this study in dedicated locations with rapid imaging and blood tests to help the scientific community, the patients and their physicians understand what we are dealing with in the medium to long term,” Xu noted.
Adapting equipment and expertise
“The study was borne out of a desire to turn our medical imaging and obesity and inflammation phenotyping expertise to support the global COVID-19 effort,” Hounsell said. “[R]esearch highlighting the multi-organ involvement have played a big role in the final decision to undertake this research.”
The Coverscan study will employ the company’s “postprocessing software, which uses MRI to assess tissue characteristics,” Hounsell said.
The company’s lead product is Livermultiscan, a diagnostic aid for liver disorders that uses multiparametric MRI to measure fat, fibrosis, inflammation, and correlates of iron in the organ. Livermultiscan is the only FDA-cleared technology that has proven accuracy and precision in assessment of liver tissue, according to the company. Delivered as a service, it does not require additional hardware and is standardized across MRI manufacturers and field strengths.
Obesity has been shown to more than double the risk of hospitalization for COVID-19 patients. In addition, elevated liver enzymes and hypertension also increase risk of complications, according to studies from China, Europe and the U.S.
That suggested that more than “70 million Americans with obesity, who are therefore at risk of steatohepatitis and metabolic syndrome, should take particular precautions,” the company said. Further, “genetics of liver inflammation may help stratify high-risk obese patients, and MRI with Livermultiscan is a well-established, safe and accurate method of assessing liver inflammation.
"Understanding the impact of COVID-19 on specific patient populations, such as those with obesity, diabetes, fatty liver disease and NASH [non-alcoholic steatohepatitis] is essential to providing actionable advice to clinicians and patients to provide optimal care and avoid needless deaths. The Global Liver Institute is committed to working with researchers and innovators around the world like Perspectum to rapidly assess and inform a robust response to this pandemic,” said Donna Cryer, president and CEO of the Global Liver Institute.
Perspectum announced April 14 that it had raised $36 million in financing from new and existing investors to fund commercialization of Livermultiscan for clinical use, expand its imaging-focused contract research organization solutions business, and enable development of additional products.
The round was co-led by Blue Venture Fund and Healthquest Capital along with Oxford Science Innovation, Puhua Capital, and the University of Oxford.
“Perspectum is addressing a large medical need with very few current solutions and has the opportunity to become the standard of care for liver disease diagnosis as a first application,” said Garheng Kong, managing partner of Belmont, Calif.-based Healthquest Capital. “We believe there is an opportunity to build a best-in-class medical imaging company for multiple clinical indications and are excited to work alongside BVF to help Perspectum realize this vision.”