PHOENIX — An investigational drug used to treat patients with COVID-19 is moving to Phase 3 of testing in Phoenix and Scottsdale.
HonorHealth Research Institute announced Wednesday it started enrolling participants in a clinical trial of novel drug ruxolitinib at three of its hospitals in the Phoenix-metro.
Phase 3, a randomized controlled 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.
“For our sickest patients with COVID-19 infection, those in intensive care on ventilators, we are sorely in need of new options, and this study could potentially reduce the duration of time that patients are intubated on ventilators,” stated Michael S Gordon, MD, principal investigator of the study.
Researchers throughout the country expect to enroll approximately 500 participants with confirmed COVID-19 infection that must have been confirmed two weeks prior to randomization. Participants must also be intubated and be receiving mechanical ventilation at the time of randomization, among other criteria.
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, but positive clinical trial results could lead to a pathway for FDA approval for this use.
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. For more information on this study including eligibility criteria visit ClinicalTrials.gov or email email@example.com.