Advocate Aurora Research Institute has begun enrolling participants in a clinical trial at Aurora St. Luke’s Medical Center in Milwaukee to study an investigational drug to treat patients with COVID-19.
The randomized controlled Phase 3 trial compares the safety and efficacy of two different doses of the drug ruxolitinib to placebo in participants with COVID-19-associated acute respiratory distress syndrome (ARDS) who are on a ventilator.
There are currently no approved treatments for COVID-19-associated ARDS. About 14% of patients with COVID-19 develop severe disease requiring hospitalization and oxygen support, 5% require admission to an intensive-care unit, according to a recently published study in the journal China CDC Weekly.
“Within the national discussion surrounding COVID-19 medical equipment needs, ventilators have come to be viewed as a cure-all,” said critical care specialist Charles Ojielo, MD. “Unfortunately, for the patients with COVID-19 who develop ARDS, prior studies show the disease has a 50% to 80% mortality rate, despite any ‘treatment’ that a mechanical ventilator might provide.”
Researchers throughout the country expect to enroll approximately 500 participants ages 12 and older with COVID-19 infection confirmed within two weeks prior to randomization. Participants must also be intubated and receiving mechanical ventilation at the time of randomization, among other criteria.
Prior studies have shown that many patients with severe respiratory disease due to COVID-19 have features consistent with cytokine release syndrome (CRS), or “cytokine storm,” an uncontrolled and overwhelming release of proinflammatory proteins throughout the body.
“Laboratory evidence and new, preliminary data suggest that drugs, such as ruxolitinib, that block a specific signaling pathway, could help prevent the cytokine storm that proves fatal for many patients with COVID-19,” said Nina Garlie, PhD, interim vice president for the Research Institute.
Ruxolitinib is approved by the U.S. Food and Drug Administration for the treatment of adult patients with intermediate or high-risk myelofibrosis, polycythemia vera after resistance or intolerance to hydroxyurea, and steroid refractory acute graft versus host disease. Ruxolitinib is not approved for the treatment of patients with COVID-19 ARDS who are on a ventilator.
The study will compare two doses of ruxolitinib – 5 mg and 15 mg twice daily – plus standard of care to placebo plus standard of care for a period of up to 28 days.
The study, “A phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of ruxolitinib in participants with COVID-19-associated ARDS who require mechanical ventilation (RUXCOVID-DEVENT),” is sponsored by Incyte Corporation, the manufacturer of the drug in the U.S.