Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04404361
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404361
Recruitment Status : Active, not recruiting
First Posted : May 27, 2020
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE May 27, 2020
Last Update Posted Date April 23, 2021
Actual Study Start Date  ICMJE May 22, 2020
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
Proportion of patients who progress to IMV and/or ECMO or death during the 28 days following randomization [ Time Frame: 28 days ]
The proportion is calculated as the number of patients who progress divided by the total number of patients in the ITT population.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
The primary efficacy endpoint is the proportion of patients who progress to IMV and/or ECMO or death during the 28 days following randomization [ Time Frame: 28 days ]
The proportion is calculated as the number of patients who progress divided by the total number of patients in the ITT population.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID19
  • COVID-19
  • COVID
Intervention  ICMJE
  • Drug: Pacritinib
    100 mg capsules
    Other Names:
    • SB1518
    • Oral Jak Inhibitor
    • Oral Irak inhibitor
    • Oral Csf1 inhibitor
  • Drug: Placebo
    Placebo capsules matching pacritinib 100 mg capsules
Study Arms  ICMJE
  • 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
    Intervention: Drug: Pacritinib
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 21, 2021)
200
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
358
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04404361
Other Study ID Numbers  ICMJE PAC319
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CTI BioPharma
Study Sponsor  ICMJE CTI BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CTI BioPharma
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP