PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
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| ClinicalTrials.gov Identifier: NCT04404361 |
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Recruitment Status :
Terminated
(decision to close enrollment early)
First Posted : May 27, 2020
Last Update Posted : September 28, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID19 COVID-19 COVID | Drug: Pacritinib Drug: Placebo | Phase 3 |
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 : | 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 |
| Actual Primary Completion Date : | September 21, 2021 |
| Actual Study Completion Date : | September 21, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Pacritinib
100 mg capsules
Other Names:
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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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Drug: Placebo
Placebo capsules matching pacritinib 100 mg capsules |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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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: | September 28, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID19 COVID-19 COVID |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |