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.
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.
Drug: Pacritinib
100 mg capsules
Other Name: Array
Drug: Placebo
Placebo capsules matching pacritinib 100 mg capsules
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
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
Orange, California, United States
Ascension St. Vincent's Riverside Hospital
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
St. Vincent Medical Group, Inc
Indianapolis, Indiana, United States
St. Agnes Healthcare
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Ascension Providence Hospital - Novi Campus
Novi, Michigan, United States
Providence Cancer Institute
Southfield, Michigan, United States
Atlantic Melanoma Center
Morristown, New Jersey, United States
Overlook Medical Center
Morristown, New Jersey, United States
Chilton Medical Center
Pompton Plains, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
St. John Medical Center
Tulsa, Oklahoma, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Ascension St. Francis Hospital
Milwaukee, Wisconsin, United States
Ascension All Saints
Racine, Wisconsin, United States