A potentially fatal inflammatory response that occurs in some people with COVID-19 infections may be alleviated with a medication that's being assessed in a study at Virginia Commonwealth University.
The drug, canakinumab, is FDA approved for treating a form of juvenile arthritis and some other inflammatory conditions. It is being tested as a treatment to calm a cytokine storm. Cytokines are proteins that are thought to overreact in some people with pneumonia and COVID-19, causing the body to attack itself, according to VCU researcher and cardiologist Antonio Abbate. That can lead to organ shutdown and death.
Antonio Abbate (Photo courtesy VCU Health)
The medication will be tested in patients who have tested positive for COVID-19, have pneumonia and difficulty breathing but don't require a ventilator, and are experiencing a cytokine storm, in an attempt to modulate the cytokine storm, according to Abbate.
Canakinumab has been used for several years to treat a type of juvenile arthritis and some rare autoinflammatory diseases. Abbate says the drug has been proven to work, and that the study seeks to show whether it is useful in helping the COVID-19 patients heal more quickly and head off the need for placing them on ventilators, “which is one of the most dreaded consequences,” he says.
Cytokine storms occur in a minority of patients, Abbate says, but there are no firm numbers on the occurrence.
As of May 19, there were 199 novel coronavirus patients in Virginia who were on ventilators, according to the Virginia Hospital & Healthcare Association. There were 1,497 hospitalized with confirmed or suspect COVID-19 infections and 377 in ICUs; 4,271 Virginians have been hospitalized for coronavirus and released.
The study involves a single-dose treatment, a one-time infusion that's expected to last for weeks, says Abbate.
VCU is one of several sites for the study of the Novartis medication. The study is double-blind and placebo-controlled, with an expected enrollment of 450 patients overall. Participants also will receive standard-of-care, which may include other treatments and supportive care.
Currently, there is no accepted treatment for a cytokine storm, just supportive care. As with all patients in treatment at VCU, trial participants are offered access to convalescent plasma from people who have recovered from COVID-19. They may also be treated with other anti-inflammatory medications used off label.
Abbate is a cardiologist who is an associate director of VCU's C. Kenneth and Dianne Wright Center for Clinical and Translational Research and medical director of the clinical research unit for VCU Health. An associate professor of cardiology for the medical school, he is the principal investigator in the canakinumab study, which began April 29. School of Pharmacy professor Benjamin Van Tassell is a co-investigator. Abbate was familiar with the drug, which was previously studied at VCU. He says that it has been shown to reduce the recurrence of a second heart attack or stroke in people who have previously sustained a heart attack.
