Ruxolitinib for Emergency Treatment of COVID-19–Associated Cytokine Storm: Findings From an Expanded Access Study

Abstract

Introduction: This expanded access program (EAP) provided ruxolitinib (oral, selective Janus kinase [JAK]1/JAK2 inhibitor) for emergency treatment of COVID-19–associated cytokine storm in patients eligible for hospitalization (NCT04355793). Methods: Patients received ruxolitinib 5 mg twice daily (preferred regimen when tolerated) or once daily for ≤ 14 days, or until determination of no clinical benefit was made. Outcomes were clinical status, physician-assessed clinical benefit, and serious adverse event (SAE) incidence. Results: Of 312 patients, 45.5% achieved ≥ 1-point clinical status improvement. Physician-assessed clinical benefit was reported in 42.6% of evaluable patients. SAEs occurred in 42.9%, with 2.6% experiencing an SAE suspected to be ruxolitinib related. Conclusions: Overall, some hospitalized patients with COVID-19–associated cytokine storm who received ruxolitinib experienced clinical status improvement; ruxolitinib was well tolerated. Trial Registration: ClinicalTrials.gov identifier: NCT04355793.