HonorHealth Research Institute has begun enrolling participants in a clinical trial at three hospitals within the HonorHealth system in Phoenix and Scottsdale 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.
In a recently published article, the Journal of the American Medical Association reported that of the patients with COVID-19 who were hospitalized, 14.2% were treated in the intensive care unit and of those patients, 85.9% received mechanical ventilation.
“For our sickest patients with COVID-19 infection, those in intensive care on ventilators, we are sorely in need of new options, 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 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 pro-inflammatory proteins throughout the body.
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 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 protected]
HonorHealth Research Institute continues to assess possibilities for improving the management of patients infected with COVID-19. The HonorHealth Research Institute is focused on expanding its portfolio of treatment options to help support patients and their families fighting COVID-19 in the community.