Status:
TERMINATED
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Lead Sponsor:
CTI BioPharma
Conditions:
COVID19
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 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...
Detailed Description
This is a Phase 2 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...
Eligibility Criteria
Inclusion
- 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).
- Age ≥ 18 years
- Platelet count ≥ 50,000/µL
- If fertile, willing to use effective birth control methods during the study
- Provision of informed consent within 96 hours after hospitalization
Exclusion
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Currently intubated or intubated between screening and randomization
- Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID 19)
- Prior allogenic hematopoietic stem cell transplantation
- Active lung cancer or history of lung cancer within the past 12 months
- Any active grade 2 or higher hemorrhage
- Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
- Uncontrolled intercurrent illness that, in the judgment of the treating physician, would limit compliance with study requirements
- Known seropositivity for human immunodeficiency virus with cluster of differentiation 4 (CD4) count \< 200/mm3 within 3 months prior to randomization
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- Concurrent enrollment in another interventional trial (investigational COVID-19 antiviral studies are permitted)
- Serum creatinine \> 2.5 mg/dL
- Total bilirubin \> 4× the upper limit of normal
- QT corrected by the Fridericia method (QTcF) prolongation \> 480 msec
- Known history of New York Heart Association Class II, III, or IV congestive heart failure prior to hospital admission
- Known allergic reaction to any Janus kinase 2 (JAK2) inhibitor
- Exposure to any JAK2 inhibitor within 28 days
- 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
- Treatment with cytoreductive chemotherapy administered within 14 days prior to randomization
- Administration of an IL 1 or IL 6 blocking immunomodulatory agent (such as tocilizumab, canakinumab, sarilumab, anakinra) within 48 hours prior to randomization
- 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.
- Unable to ingest capsules or tablets at randomization
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04404361
Start Date
May 22 2020
End Date
September 21 2021
Last Update
June 5 2024
Active Locations (21)
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1
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
Orange, California, United States, 92868
2
Ascension St. Vincent's Riverside Hospital
Jacksonville, Florida, United States, 32204
3
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
4
St. Vincent Medical Group, Inc
Indianapolis, Indiana, United States, 46220