Keck Medicine of USC physicians are launching a clinical trial to evaluate the efficacy and safety of baricitinib, an anti-inflammatory drug approved by the Food and Drug Administration to treat rheumatoid arthritis, as a possible treatment for patients with moderate to severe COVID-19.
“We are learning that in some COVID-19 cases, inflammation might be driving the need for intubation and causing poor outcomes,” said Michael Dube, MD, an infectious disease specialist at Keck Medicine.
Dube is heading up the trial with Heinz-Josef Lenz, MD, associate director of clinical research of the USC Norris Comprehensive Cancer Center, who serves as the principal investigator.
For certain patients, COVID-19 may trigger a “cytokine storm,” explained Dube, who is also interim chief of the division of infectious diseases at the Keck School of Medicine of USC. Cytokines are small proteins in the body that help the immune system battle infection. However, having a large amount released into the body all at once can result in excess inflammation that causes tissue damage and organ failure.
Baricitinib has been shown to lower levels of a cytokine known as interleukin-6, as well as other 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,” said Dube.
The drug is one of several anti-inflammatories being tested for use in patients with COVID-19.
Dube and Lenz will collaborate with Bodour Salhia, PhD, an assistant professor of translational genomics at the Keck School, on related but different research. Salhia will collect blood samples drawn during the trial to look for molecular biomarkers to identify COVID-19 patients who are at high-risk for developing severe outcomes. Salhia will use a liquid biopsy methodology she has already developed for cancer research.
“Finding such biomarkers will lead to better management and protection of high-risk individuals,” she said.
The clinical trial is a double-blind, randomized controlled study. Half the participants will receive baricitinib in the form of a daily tablet medication and the other half will receive a placebo. Researchers plan to enroll 144 patients from Keck Hospital of USC, USC Verdugo Hills Hospital and Los Angeles County + USC Medical Center.
Participants will include patients who exhibit COVID-19 symptoms but have not reached the stage where they have to be intubated. Patients with a heightened risk factor for the virus, such as those 60 or older, or with a chronic heart or lung condition, obesity, hypertension or diabetes, are also eligible.
— Alison Rainey
The pharmaceutical company Eli Lilly and Company provided funding for this study.