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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID19, COVID-19, COVID

In brief

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.

Key facts

Study ID

NCT04404361

Run by

CTI BioPharma

People needed

200

Starts

2020-05-22

Expected to finish

2021-09-21

Last updated by the study team

2024-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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