PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer

Exclusion Criteria

• •1. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
• •2. Currently intubated or intubated between screening and randomization
• •3. Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID 19)
• •4. Prior allogenic hematopoietic stem cell transplantation
• •5. Active lung cancer or history of lung cancer within the past 12 months
• •6. Any active grade 2 or higher hemorrhage
• •7. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
• •8. Uncontrolled intercurrent illness that, in the judgment of the treating physician, would limit compliance with study requirements
• •9. Known seropositivity for human immunodeficiency virus with cluster of differentiation 4 (CD4) count \< 200/mm3 within 3 months prior to randomization
• •10. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
• •11. Concurrent enrollment in another interventional trial (investigational COVID-19 antiviral studies are permitted)
• •12. Serum creatinine \> 2.5 mg/dL
• •13. Total bilirubin \> 4× the upper limit of normal
• •14. QT corrected by the Fridericia method (QTcF) prolongation \> 480 msec
• •15. Known history of New York Heart Association Class II, III, or IV congestive heart failure prior to hospital admission
• •16. Known allergic reaction to any Janus kinase 2 (JAK2) inhibitor
• •17. Exposure to any JAK2 inhibitor within 28 days
• •18. Currently receiving a strong CYP3A4 inhibitor or strong P450 inducer (Appendix 1 and Appendix 2, respectively) and unable to stop the medication prior to the first dose of study drug and throughout the duration of study drug administration
• •19. Treatment with cytoreductive chemotherapy administered within 14 days prior to randomization
• •20. Administration of an IL 1 or IL 6 blocking immunomodulatory agent (such as tocilizumab, canakinumab, sarilumab, anakinra) within 48 hours prior to randomization
• •21. Currently receiving therapeutic anticoagulation or anti platelet medication and unable to stop the medication prior to randomization. Prophylactic anticoagulation therapy or aspirin (≤ 100mg) are permitted.
• •22. Unable to ingest capsules or tablets at randomization