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

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.