UW School of Medicine and Public Health part of new clinical trial to combat COVID-19

In less than two weeks, the school was able to complete the process to become a clinical trial site examining the drug ruxolitinib, to combat cytokine storm in patients with severe COVID-19 infection, said David Andes, professor of medicine in the infectious disease division and principal investigator at the UW clinical trial site.

“Working with Novartis was very efficient, and they were accessible for questions,” he said. “Everyone at UW dropped what they were doing to try and get our patients access to a potentially beneficial therapy through a clinical trial that would provide critical answers for future care of this patient population for which we still have no defined optimal therapy.”

This process should have taken many months, which is typical in the case for some experimental trials, but because of the strength of industry and academic partnerships and of the clinical trial infrastructure at the school and UW Health, it took less than three weeks, according to Betsy Nugent, director of clinical trials development and accreditation/chief clinical research officer at SMPH.

“What typically takes a long time ­(for good reason) we were able to make happen at lighting speed, to address one of the most pressing medical needs of modern times,” she said. “While we may not have the volume of patients as harder hit areas of the country, this has allowed our doctors and researchers more availability to respond to the research challenge of developing new treatments.”

Cytokine storm occurs when a person’s own immune system overreacts to what it perceives as invading pathogens, such as viruses. During the normal course of an infection, the body generates blood proteins called cytokines that cause threatened cells to die to prevent the spread of the virus to other cells. However, when the body releases too many cytokines too quickly, it can result in damaged organs and be life-threatening. In the lungs, it can starve the body of oxygen.

The trial, conducted in partnership between Novartis and Incyte, is a placebo-controlled treatment study with a drug that inhibits the JAK/STAT pathway, which is a channel of communication between proteins in a cell, Andes said.

“It is thought this treatment may prevent or treat the same syndrome that is linked to multisystem organ failure in a subset of patients with COVID-19,” he said.

Working with Nugent, the UW Office of Clinical Trials and the UW Institutional Review Board, Andes and his team established a collaboration with Novartis in less than two weeks and became a site for the trial, which is currently enrolling patients.

The ruxolitinib trial is one of several clinical trials under way at the school to fight COVID-19, learn more about clinical trials at the school or UW Health.