A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Overview
- Phase
- Phase 2
- Intervention
- Pacritinib
- Conditions
- COVID19
- Sponsor
- CTI BioPharma
- Enrollment
- 200
- Locations
- 21
- Primary Endpoint
- Percentage of Participants With Progression to IMV and/or ECMO or Death
- Status
- Terminated
- Last Updated
- last year
Overview
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. 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Pacritinib and SOC
Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC
Intervention: Pacritinib
Placebo and SOC
4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Participants With Progression to IMV and/or ECMO or Death
Time Frame: Baseline to Day 28
The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \* 100).
Secondary Outcomes
- The Mortality Rate at Day 15(Baseline to Day 15)
- The Number of Ventilator-Free Days(Baseline to Day 28)
- The Mortality Rate at Day 28(Baseline to Day 28)
- The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28(Baseline, Day 8, 15, 22, 28)
- The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status(Baseline, Day 8, 15, 22, and 28.)
- The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19(Baseline to Day 28)