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

NCT04404361 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: PAC319
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

COVID-19; COVID

Keywords

COVID19; COVID-19; COVID

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression to IMV and/or ECMO or Death

  The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \* 100).

  Baseline to Day 28

Secondary Outcomes (6)

• The Number of Ventilator-Free Days

  Baseline to Day 28

• The Mortality Rate at Day 28

  Baseline to Day 28

• The Mortality Rate at Day 15

  Baseline to Day 15

• The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status

  Baseline, Day 8, 15, 22, and 28.

• The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28

  Baseline, Day 8, 15, 22, 28

Study Arms (2)

Pacritinib and SOC

EXPERIMENTAL

Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC

Drug: Pacritinib

Placebo and SOC

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pacritinib DRUG

100 mg capsules

Also known as: SB1518, Oral Jak Inhibitor, Oral Irak inhibitor, Oral Csf1 inhibitor

Pacritinib and SOC

Placebo DRUG

Placebo capsules matching pacritinib 100 mg capsules

Placebo and SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (21)

St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare

Orange, California, 92868, United States

Location

Ascension St. Vincent's Riverside Hospital

Jacksonville, Florida, 32204, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

St. Vincent Medical Group, Inc

Indianapolis, Indiana, 46220, United States

Location

St. Agnes Healthcare

Baltimore, Maryland, 21229, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Ascension Providence Hospital - Novi Campus

Novi, Michigan, 48374, United States

Location

Providence Cancer Institute

Southfield, Michigan, 48075, United States

Location

Atlantic Melanoma Center

Morristown, New Jersey, 07960, United States

Location

Overlook Medical Center

Morristown, New Jersey, 07960, United States

Location

Chilton Medical Center

Pompton Plains, New Jersey, 07444, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Ascension St. Francis Hospital

Milwaukee, Wisconsin, 53215, United States

Location

Ascension All Saints

Racine, Wisconsin, 53405, United States

Location

Related Publications (1)

• Cafardi J, Miller C, Terebelo H, Tewell C, Benzaquen S, Park D, Egan P, Lebovic D, Pettit K, Whitman E, Tremblay D, Feld J, Buckley S, Roman-Torres K, Smith J, Craig A, Mascarenhas J. Efficacy and Safety of Pacritinib vs Placebo for Patients With Severe COVID-19: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2242918. doi: 10.1001/jamanetworkopen.2022.42918.

  PMID: 36469321 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene; Janus Kinase Inhibitors

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: John Volpone
• Organization: CTI BioPharma Corp.

jvolpone@ctibiopharma.com

206-351-7663

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: May 22, 2020
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Locations

US (21)