Keck Medicine of USC will launch a clinical trial to study the effects of an anti-inflammatory drug on treating patients with the coronavirus, according to a Wednesday press release from Keck Medicine. The medication, baricitinib, has been approved by the Food and Drug Administration to treat rheumatoid arthritis.
Inflammation resulting from the virus may be the underlying cause behind severe respiratory complications that require hospitalization and intubation, said Dr. Michael Dube, a Keck Medicine infectious disease specialist and the Keck School of Medicine interim chief of infectious diseases, in the press release.
“The primary problem that is occurring in people who develop critical illness … is excessive inflammation in the body, and that affects the lungs and other organs,” Dube said. “[Baricitinib] appears to be able to affect some of the key inflammation pathways that are leading to critical illness in COVID-19.”
Dube is conducting the trial alongside Heinz-Josef Lenz, associate director of clinical research at the USC Norris Comprehensive Cancer Center, who serves as the main investigator in the study. Dube said the researchers hope to start enrolling patients in the study starting Thursday.
The double-blind study, which will run for three months, is expected to survey the effects of baricitinib on 144 random patients with moderate to severe coronavirus infections from Los Angeles County + USC Medical Center, Keck Hospital of USC and USC Verdugo Hills Hospital. Half of the patients will receive the drug, while the other half will receive a placebo.
Participants will include patients who exhibit moderate to severe symptoms of the coronavirus infection but who have not reached a critical stage requiring intubation. Patients with higher risk factors are also eligible to participate.
According to Dube, patients with moderate disease have at least one risk factor — age greater than 60, diabetes, morbid obesity or high blood pressure — in addition to the coronavirus and signs of pneumonia. Patients with severe disease have low oxygen levels in their blood.
For some patients, the virus can trigger a cytokine storm, an immune response with a large number of small infection-fighting proteins which in greater quantities can damage tissue and lead to organ failure, Dube said. Research has indicated that baricitinib lowers the levels of certain cytokines.
“Our premise is that by using baricitinib to reduce the inflammation, we may be able to slow down the progress of the disease, stop the need for a ventilator and save lives,” Dube said in the press release.
Dube and Lenz will also work with Keck School of Medicine assistant professor of translational genomics Bodour Salhia during the trial. Salhia will collect blood samples from patients to look for molecular biomarkers to identify people who are at high risk for developing severe symptoms.
In addition to piloting the study, Keck Medicine resumed a limited number of medically necessary and time-sensitive procedures and surgeries at select locations, including Verdugo Hills Hospital and Keck Medical Center, Monday. Nonemergent but medically necessary elective operations, along with gynecological, orthopedic and general surgeries, are some of the services that have resumed and will be expanded May 11.
In a Monday press release, Keck Medicine said it is resuming services in accordance with public health guidelines. The medical center said it is maintaining the health and safety of its employees by providing personal protective equipment, screening for fevers upon entrance into its facilities, testing patients for the coronavirus at least 72 hours in advance of their procedures and continuing its telemedicine services for nonemergent services.