VCU news

By Jackie Kruszewski
C. Kenneth and Dianne Wright Center for Clinical and Translational Research

Virginia Commonwealth University researchers have joined a growing study to test a drug developed to treat rheumatoid arthritis on patients who are critically ill with symptoms of the novel coronavirus, COVID-19.

Sarilumab works to block interleukin-6, which signals the body’s immune system to create the excess inflammation seen in sufferers of rheumatoid arthritis. Doctors hope it will do the same for patients whose severe COVID-19 has led to uncontrolled inflammation in the lungs.

“Finding interventions that treat COVID-19, a disease without any approved treatment, and its additional symptoms has been a challenge facing researchers globally,” said Marjolein de Wit, M.D., the study’s principal investigator and a pulmonary and critical care physician at VCU Health. “These clinical trials are intended to evaluate whether this drug is safe and effective against hyper-inflammation — also called cytokine storm — in pneumonia and acute respiratory distress syndrome related to COVID-19. We are proud to be testing this drug for its safety and efficacy to determine if it could be useful for treating patients in the future.”

The clinical trial to test sarilumab, currently underway at more than 60 sites, has nine patients enrolled at VCU. Many of the trial sites are in New York and New Jersey where the drug’s sponsors, Regeneron and Sanofi, are based, but VCU researchers worked to bring the trial to Richmond after researching it.

“There has been some data from China and Italy with a similar drug that was promising, but the data was not placebo-controlled,” said cardiologist Antonio Abbate, M.D., Ph.D., medical director of the Clinical Research Unit at VCU Health and a co-investigator on the study. “So we were excited to be able to join this study to contribute to a fuller understanding of sarilumab’s potential.”

These clinical trials are intended to evaluate whether this drug is safe and effective against hyper-inflammation — also called cytokine storm — in pneumonia and acute respiratory distress syndrome related to COVID-19.

Abbate is an associate director at the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, which oversees clinical trials at VCU with the help of a $21.5 million National Institutes of Health award. The Clinical Research Unit is unique, dedicated space at VCU Health used for clinical trials, and its staff has been heavily involved in the COVID-19 trials.

“The collaboration between VCU and VCU Health to get this clinical trial and others off the ground rapidly while putting patients’ safety first has been a coordinated team effort,” said F. Gerard Moeller, M.D., director of the Wright Center. “This team’s work with study participants will increase the world’s knowledge of whether certain drugs will reduce the inflammation that is common in pneumonia related to COVID-19, and we are proud of the work they are doing to ensure the safety and efficacy of any drug with the potential to have an impact on this disease.”

VCU has also enrolled participants in clinical trials on remdesivir.

To qualify for the sarilumab study, patients must be hospitalized in the intensive care unit with severe COVID-19 and pneumonia and must require the help of ventilators or other high-flow oxygen support.

According to Abbate’s interpretation of the available data, the severe hypoxemia seen in the later phase of COVID-19 pneumonia in some patients is related not to the virus itself but more to an overwhelming inflammatory response (hyper-inflammation). Stopping excessive inflammation could blunt the effects of COVID-19 related pneumonia, said Abbate, whose research on inflammation at the Pauley Heart Center at VCU Health has involved repurposing anti-inflammatory drugs to reduce the likelihood of heart failure.

Results from the multicenter study are expected in June, according to Regeneron.

Carla Davis and Mary Kate Brogan contributed to this article.