RUXCOVID (NCT04362137) is a global, randomized, double-blind, placebo-controlled, 29-day, multi-center, Phase 3 study evaluating the efficacy and safety of ruxolitinib (Jakafi®) plus standard of care (SoC) therapy in patients aged ≥12 years with COVID-19 associated cytokine storm compared to placebo plus SoC therapy. The study will enroll approximately 400 patients globally.
The composite primary endpoint is the proportion of patients who die, develop respiratory failure (require mechanical ventilation), or require intensive care unit (ICU) care by Day 29. Secondary endpoints are comprised of various efficacy assessments including evaluation of clinical status using a 9-point ordinal scale; in-hospital outcomes including mortality rate, proportion of patients requiring mechanical ventilation, duration of hospitalization, ICU stay, supplemental oxygen and/or invasive mechanical ventilation; change in the National Early Warning Score (NEWS2); change in SpO2/FiO2 ratio; proportion of patients with no oxygen therapy (oxygen saturation of ≥94% on room air); and safety.
Eligible patients will be randomized 2:1 to receive oral ruxolitinib 5mg twice daily (BID) or oral-matching placebo for a total of 14 days. Study treatment will be given in combination with SoC therapy according to the investigator’s clinical judgement. After 14 days of therapy, should clinical signs or symptoms not improve or worsen, patients may receive an additional 14 days of study therapy. In total, patients will be followed on study for 29 days post-randomization.
The RUXCOVID study is sponsored by Incyte in the United States, and Novartis outside of the United States. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04362137.