PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
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.
Inclusion Criteria
- 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 Criteria
- 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04404361.
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. Severe COVID-19 is defined as confirmed disease in
patients who are hospitalized with hypoxia (blood oxygen saturation [SpO2] ≤93% on room
air at sea level), respiratory rate >30, arterial oxygen partial pressure [PaO2]/
fraction of inspired oxygen [FiO2] <300, or lung infiltrates >50% but do not require IMV.
Patients will be randomized 1:1 to receive pacritinib (400 mg once daily [QD] on Day 1,
then 200 mg twice daily [BID] from Day 2 to Day 14) + SOC or placebo + SOC.
Assigned treatment will continue for up to Day 14 or until the patient experiences
intolerable adverse events (AEs), withdraws consent, or initiates another investigational
therapy or until the study is terminated. Assigned therapy may be given for an additional
7 days (for a total of 21 days) with the approval of the Medical Monitor if, in the
opinion of the investigator, the patient's clinical signs and symptoms are improving and
the potential benefit outweighs the potential risk.In the event of hospital discharge,
patients will complete treatment with the assigned therapy as an outpatient.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationCTI BioPharma
- Primary IDPAC319
- Secondary IDsNCI-2020-05184
- ClinicalTrials.gov IDNCT04404361