- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404361
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Orange, California, United States, 92868
- St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
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Florida
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Jacksonville, Florida, United States, 32204
- Ascension St. Vincent's Riverside Hospital
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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Indiana
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Indianapolis, Indiana, United States, 46220
- St. Vincent Medical Group, Inc
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Maryland
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Baltimore, Maryland, United States, 21229
- St. Agnes Healthcare
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Detroit, Michigan, United States, 48236
- Ascension St. John Hospital
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Novi, Michigan, United States, 48374
- Ascension Providence Hospital - Novi Campus
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Southfield, Michigan, United States, 48075
- Providence Cancer Institute
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New Jersey
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Morristown, New Jersey, United States, 07960
- Atlantic Melanoma Center
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Morristown, New Jersey, United States, 07960
- Overlook Medical Center
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Pompton Plains, New Jersey, United States, 07444
- Chilton Medical Center
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
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Oklahoma
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Tulsa, Oklahoma, United States, 74104
- St. John Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Providence, Rhode Island, United States, 02903
- The Miriam Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- Ascension St. Francis Hospital
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Racine, Wisconsin, United States, 53405
- Ascension All Saints
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Concurrent enrollment in another interventional trial (investigational COVID-19 antiviral studies are permitted)
- Serum creatinine > 2.5 mg/dL
- Total bilirubin > 4× the upper limit of normal
- QT corrected by the Fridericia method (QTcF) prolongation > 480 msec
- Known history of New York Heart Association Class II, III, or IV congestive heart failure prior to hospital admission
- Known allergic reaction to any Janus kinase 2 (JAK2) inhibitor
- Exposure to any JAK2 inhibitor within 28 days
- 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
- Treatment with cytoreductive chemotherapy administered within 14 days prior to randomization
- Administration of an IL 1 or IL 6 blocking immunomodulatory agent (such as tocilizumab, canakinumab, sarilumab, anakinra) within 48 hours prior to randomization
- 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.
- Unable to ingest capsules or tablets at randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
100 mg capsules
Other Names:
|
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
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Placebo capsules matching pacritinib 100 mg capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Janus Kinase Inhibitors
Other Study ID Numbers
- PAC319
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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