COVID19Phase 2NCT04404361
PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
A Phase 2 study testing Pacritinib in people with COVID19 and COVID-19, run by CTI BioPharma at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Pacritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 21 sitesUnited States
- Study dates
- 22 May 2020to 21 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109
Grady Memorial Hospital
Atlanta, Georgia, 30303
St. Agnes Healthcare
Baltimore, Maryland, 21229
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Ascension St. John Hospital
Detroit, Michigan, 48236
St. Vincent Medical Group, Inc
Indianapolis, Indiana, 46220
Ascension St. Vincent's Riverside Hospital
Jacksonville, Florida, 32204
Ascension St. Francis Hospital
Milwaukee, Wisconsin, 53215
Atlantic Melanoma Center
Morristown, New Jersey, 07960
Overlook Medical Center
Morristown, New Jersey, 07960
Mount Sinai Medical Center
New York, New York, 10029
Ascension Providence Hospital - Novi Campus
Novi, Michigan, 48374
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
Orange, California, 92868
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Chilton Medical Center
Pompton Plains, New Jersey, 07444
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02903
Ascension All Saints
Racine, Wisconsin, 53405
Providence Cancer Institute
Southfield, Michigan, 48075
St. John Medical Center
Tulsa, Oklahoma, 74104
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Pacritinib, Placebo
- Keywords
- COVID19, COVID-19, COVID
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
Also called SB1518, Oral Jak Inhibitor, Oral Irak inhibitor, Oral Csf1 inhibitor
100 mg capsules
PlaceboDrug
Placebo capsules matching pacritinib 100 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Day 28
Secondary outcomes (6)
The Number of Ventilator-Free Days
the number of days that patients are alive and not intubated, from randomization to Day 28
Measured: Baseline to Day 28
The Mortality Rate at Day 28
the number of patients with outcome of death during the 28 days following randomization
Measured: Baseline to Day 28
The Mortality Rate at Day 15
the number of patients with outcome of death in the 15 days following randomization
Measured: 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
Time to Improvement (days) = Date of improvement - Date of randomization + 1. Date of Improvement was defined as the time to first ordinal scale assessment 2 points or more lower than the baseline clinical status assessment.
Measured: 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
Clinical status assessment based on the adapted scale from Cao et al. The patient CS is summarized by study visit.
STATUS:
- not hospitalized with resumption of normal activities;
- not hospitalized but unable to resume normal activities;
- hospitalization, not requiring supplemental oxygen;
- hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6;
- hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula;
- hospitalization, requiring IMV and/or ECMO;
- death.
Measured: Baseline, Day 8, 15, 22, 28
The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19
the proportion of patients reporting use of medications such as corticosteroids, tocilizumab, anakinra, or eculizumab as treatment for COVID-19, during 28 days following randomization
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start22 May 2020
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Why it stopped: decision to close enrollment early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404361
- Sponsor's protocol ID
- PAC319
- Status last verified
- May 2024
- First submitted
- 22 May 2020
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36469321
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04404361
- Acronym / sponsor ID
- PAC319
- Keywords
- COVID19, COVID-19, COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decision to close enrollment early
- Enrolment
- 200 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 5 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pacritinib and SOC | Experimental | Drug: PacritinibPacritinib 400 mg once daily [QD] on Day 1, then 200 mg twice daily [BID] from Day 2 to Day 14) + SOC |
| Placebo and SOC | Placebo comparator | Drug: Placebo4 capsules once daily [QD] on Day 1, then 2 capsules twice daily [BID] from Day 2 to Day 14) + SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacritinibAlso: SB1518, Oral Jak Inhibitor, Oral Irak inhibitor, Oral Csf1 inhibitor100 mg capsules | Drug | Pacritinib and SOC |
| PlaceboPlacebo capsules matching pacritinib 100 mg capsules | Drug | Placebo and SOC |
Primary outcome
Percentage of Participants With Progression to IMV and/or ECMO or Death
Time frame: Baseline to Day 28
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).
6 secondary outcomes
The Number of Ventilator-Free Days
Time frame: Baseline to Day 28
The Mortality Rate at Day 28
Time frame: Baseline to Day 28
The Mortality Rate at Day 15
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 8, 15, 22, 28
The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36469321Cafardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pacritinib in people with COVID19 and COVID-19, run by CTI BioPharma at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Progression to IMV and/or ECMO or Death (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.