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Ruxolitinib for Emergency Treatment of COVID-19-Associated Cytokine Storm: Findings From an Expanded Access Study
Jeffrey Weinstein1, Nikhil Jagan2, Shawnta Lorthridge-Jackson3
1Department of Clinical Quality and Infection Prevention and Control, Kettering Health Network, Dayton, Ohio, USA.
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.
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