MASKED-COVID Study to Assess Renal-Related Complications of COVID-19

The Mount Sinai Health System and RenalytixAI have announced a multi-center study designed to examine kidney-related complications and long-term outcomes linked to COVID-19. The study will be conducted in multiple centers in the United States and will utilize the artificial-intelligence enabled in vitro diagnostic platform, KidneyIntelX™, to assess the risk of progression of kidney disease as well as the risk of kidney failure in patients surviving COVID-19.

The MASKED-COVID (Multi-Center Assessment of Survivors for Kidney Disease after COVID-19) study was announced in a press release from RenalytixAI, the developers of KidneyIntelX, and will expand on the study announced in April that focuses on the impact of COVID-19 in the acute hospitalized setting. The teams expected to participate in the study include the Mount Sinai Health System Icahn School of Medicine at Mount Sinai, Yale New Haven Health/Yale School of Medicine, Michigan Medicine/University of Michigan Medical School, Johns Hopkins Medicine/The Johns Hopkins University Medical School, and Rutgers, The State University of New Jersey/Rutgers New Jersey Medical School.

The risk for new chronic kidney disease (CKD) in the short-term or longer-term progression of kidney disease in patients who have recovered from COVID-19 will be assessed via KidneyIntelX. The system will generate a unique patient risk score using diverse data points, including validated blood and urine-based biomarkers, inherited genetics, and other patient data from electronic health records, that will be incorporated into the KidneyIntelX machine learning-enabled algorithm. Mount Sinai Health System’s serologic SARS-CoV-2 testing will be used to assess a patient’s antibody levels to COVID-19 over time, providing insights into the interaction between immune response and kidney-related complications in this patient population.

F. Perry Wilson, MD, MSCE, Yale University School of Medicine and MASKED-COVID principal investigator, said, “With the pandemic spread of COVID-19 and the increased morbidity and mortality from COVID-19 in patients with diabetes, CKD, and acute kidney injury, it is imperative to define the underlying mechanisms of COVID-associated kidney disease and develop solutions to guide patient care. This can be best achieved through collaboration in all aspects including data sharing, biomarker analysis, data analytics, and clinical translation. RenalytixAI and Mount Sinai have assembled an outstanding team to address critical issues regarding COVID-19 and kidney disease.”

Evren Azeloglu, PhD, at the Icahn School of Medicine at Mount Sinai, said, “There are so many questions yet to be answered regarding COVID-19 and kidney disease. For example, we don’t yet know the risk factor and mediators of AKI to CKD transition after COVID-19. We also don’t know the predictors of long-term outcomes after COVID-19. Moreover, we need to understand how this ‘second hit’ from COVID-19 interacts with other risk factors such as underlying APOL1 genotypes to heighten the potential for proteinuric nephropathy.

The MASKED-COVID study will be coordinated by Mount Sinai. Initial research findings are expected to be reported in late 2020, with the goal of launching KidneyIntelX commercialization activities in this COVID-109 population targeted for H1 2012. For more information, visit www.mountsinai.org.