Overview
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Status:
Terminated
Terminated
Trial end date:
2021-09-21
2021-09-21
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CTI BioPharmaTreatments:
Janus Kinase Inhibitors
Criteria
Inclusion Criteria:1. Hospitalized or will be hospitalized prior to randomization for the treatment of
severe COVID-19 with SARS-CoV-2 infection confirmed by either a) a positive reverse
transcriptase polymerase chain reaction (RT PCR) or b) an antigen-based test from any
respiratory, nasopharyngeal, saliva, blood, or stool specimen at Screening or
documented within 1 week prior to the start of Screening (Severe COVID-19 is defined
as confirmed disease in patients who are hospitalized with hypoxia [SpO2 ≤93% on room
air], respiratory rate >30, PaO2/FiO2 <300, but do not require IMV).
2. Age ≥ 18 years
3. Platelet count ≥ 50,000/µL
4. If fertile, willing to use effective birth control methods during the study
5. Provision of informed consent within 96 hours after hospitalization
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