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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

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
COVID19 COVID-19 COVID Drug: Pacritinib Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : October 31, 2021

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404361


Locations
Show Show 21 study locations
Sponsors and Collaborators
CTI BioPharma
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Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT04404361    
Other Study ID Numbers: PAC319
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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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:
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Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action