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PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer

Sponsor
CTI BioPharma (Industry)
Overall Status
Terminated
CT.gov ID
NCT04404361
Collaborator
(none)
200
Enrollment
21
Locations
2
Arms
16
Actual Duration (Months)
9.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 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
Actual Study Start Date :
May 22, 2020
Actual Primary Completion Date :
Sep 21, 2021
Actual Study Completion Date :
Sep 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Pacritinib
100 mg capsules
Other Names:
  • SB1518
  • Oral Jak Inhibitor
  • Oral Irak inhibitor
  • Oral Csf1 inhibitor

    		•
    Placebo Comparator: Placebo and SOC

    4 capsules once daily [QD] on Day 1, then 2 capsules twice daily [BID] from Day 2 to Day 14) + SOC

    Drug: Placebo
    Placebo capsules matching pacritinib 100 mg capsules

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients who progress to IMV and/or ECMO or death during the 28 days following randomization [28 days]

      The proportion is calculated as the number of patients who progress divided by the total number of patients in the ITT population.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 St. Agnes Healthcare Baltimore Maryland United States 21229
    6 Brigham and Women's Hospital Boston Massachusetts United States 02115
    7 University of Michigan Ann Arbor Michigan United States 48109
    8 Ascension St. John Hospital Detroit Michigan United States 48236
    9 Ascension Providence Hospital - Novi Campus Novi Michigan United States 48374
    10 Providence Cancer Institute Southfield Michigan United States 48075
    11 Atlantic Melanoma Center Morristown New Jersey United States 07960
    12 Overlook Medical Center Morristown New Jersey United States 07960
    13 Chilton Medical Center Pompton Plains New Jersey United States 07444
    14 Mount Sinai Medical Center New York New York United States 10029
    15 The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati Ohio United States 45219
    16 St. John Medical Center Tulsa Oklahoma United States 74104
    17 Albert Einstein Medical Center Philadelphia Pennsylvania United States 19141
    18 Rhode Island Hospital Providence Rhode Island United States 02903
    19 The Miriam Hospital Providence Rhode Island United States 02903
    20 Ascension St. Francis Hospital Milwaukee Wisconsin United States 53215
    21 Ascension All Saints Racine Wisconsin United States 53405

    Sponsors and Collaborators

    • CTI BioPharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CTI BioPharma
    ClinicalTrials.gov Identifier:
    NCT04404361
    Other Study ID Numbers:
    • PAC319
    First Posted:
    May 27, 2020
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CTI BioPharma
    COVID19
    COVID-19
    COVID
    Additional relevant MeSH terms:
    COVID-19
    Janus Kinase Inhibitors

    Study Results

    No Results Posted as of Sep 28, 2021