COVID, COVID19, COVID-19
Conditions
Keywords
COVID19, COVID-19, COVID
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.
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.
Interventions
DRUGPlacebo
Placebo capsules matching pacritinib 100 mg capsules
DRUGPacritinib
100 mg capsules
Sponsors
CTI BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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). 2. Age ≥ 18 years 3. Platelet count ≥ 50,000/µL 4. If fertile, willing to use effective birth control methods during the study 5. Provision of informed consent within 96 hours after hospitalization
Exclusion criteria
1. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments 2. Currently intubated or intubated between screening and randomization 3. Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID 19) 4. Prior allogenic hematopoietic stem cell transplantation 5. Active lung cancer or history of lung cancer within the past 12 months 6. Any active grade 2 or higher hemorrhage 7. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication 8. Uncontrolled intercurrent illness that, in the judgment of the treating physician, would limit compliance with study requirements 9. Known seropositivity for human immunodeficiency virus with cluster of differentiation 4 (CD4) count \< 200/mm3 within 3 months prior to randomization 10. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 11. Concurrent enrollment in another interventional trial (investigational COVID-19 antiviral studies are permitted) 12. Serum creatinine \> 2.5 mg/dL 13. Total bilirubin \> 4× the upper limit of normal 14. QT corrected by the Fridericia method (QTcF) prolongation \> 480 msec 15. Known history of New York Heart Association Class II, III, or IV congestive heart failure prior to hospital admission 16. Known allergic reaction to any Janus kinase 2 (JAK2) inhibitor 17. Exposure to any JAK2 inhibitor within 28 days 18. 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 19. Treatment with cytoreductive chemotherapy administered within 14 days prior to randomization 20. Administration of an IL 1 or IL 6 blocking immunomodulatory agent (such as tocilizumab, canakinumab, sarilumab, anakinra) within 48 hours prior to randomization 21. 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. 22. Unable to ingest capsules or tablets at randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Progression to IMV and/or ECMO or Death | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mortality Rate at Day 28 | Baseline to Day 28 | the number of patients with outcome of death during the 28 days following randomization |
| The Mortality Rate at Day 15 | Baseline to Day 15 | the number of patients with outcome of death in the 15 days following randomization |
| The Number of Ventilator-Free Days | Baseline to Day 28 | the number of days that patients are alive and not intubated, from randomization to Day 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 | Clinical status assessment based on the adapted scale from Cao et al. The patient CS is summarized by study visit. STATUS: 1. not hospitalized with resumption of normal activities; 2. not hospitalized but unable to resume normal activities; 3. hospitalization, not requiring supplemental oxygen; 4. hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6; 5. hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula; 6. hospitalization, requiring IMV and/or ECMO; 7. death. |
| The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19 | Baseline to Day 28 | 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 |
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Pacritinib: 100 mg capsules | 99 |
| Placebo and SOC 4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC
Placebo: Placebo capsules matching pacritinib 100 mg capsules | 101 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 12 |
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | patient hospitalized and was nonverbal at the end of the study | 0 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 5 |
Baseline characteristics
| Characteristic | Pacritinib and SOC | Placebo and SOC | Total |
|---|---|---|---|
| Age, Continuous | 60.0 years | 59.0 years | 60.0 years |
| Age, Customized Age group <60 years | 48 Participants | 51 Participants | 99 Participants |
| Age, Customized Age group ≥60 years | 51 Participants | 50 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 14 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 81 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 19 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) White | 74 Participants | 72 Participants | 146 Participants |
| Region of Enrollment United States | 99 participants | 101 participants | 200 participants |
| Sex: Female, Male Female | 43 Participants | 37 Participants | 80 Participants |
| Sex: Female, Male Male | 56 Participants | 64 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 96 | 12 / 101 |
| other Total, other adverse events | 74 / 96 | 79 / 101 |
| serious Total, serious adverse events | 20 / 96 | 33 / 101 |
Outcome results
Primary
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).
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pacritinib and SOC | Percentage of Participants With Progression to IMV and/or ECMO or Death | 26 Participants |
| Placebo and SOC | Percentage of Participants With Progression to IMV and/or ECMO or Death | 25 Participants |
p-value: 0.851695% CI: [-10.55, 13.53]Cochran-Mantel-Haenszel
Secondary
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: 1. not hospitalized with resumption of normal activities; 2. not hospitalized but unable to resume normal activities; 3. hospitalization, not requiring supplemental oxygen; 4. hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6; 5. hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula; 6. hospitalization, requiring IMV and/or ECMO; 7. death.
Time frame: Baseline, Day 8, 15, 22, 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 2 | 23 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 5 | 5 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 1 | 31 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 6 | 10 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 4 | 20 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 7 | 0 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 3 | 5 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status Missing | 19 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 7 | 0 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 1 | 27 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 6 | 9 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 2 | 36 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 4 | 0 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 3 | 1 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 7 | 0 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status Missing | 12 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 5 | 4 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status Missing | 25 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 6 | 7 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 1 | 19 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 7 | 3 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status Missing | 21 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 2 | 43 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 2 | 32 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 1 | 15 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 3 | 0 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 4 | 3 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 3 | 1 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 5 | 2 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 5 | 15 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 6 | 6 participants |
| Pacritinib and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 4 | 2 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 6 | 10 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 7 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status Missing | 14 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 3 | 0 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 7 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status Missing | 15 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 1 | 11 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 3 | 3 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 4 | 11 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 5 | 20 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 6 | 14 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status Missing | 4 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 1 | 17 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 2 | 47 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 3 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 4 | 8 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 5 | 2 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 6 | 16 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status 7 | 2 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 15: Clinical status Missing | 8 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 1 | 24 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 2 | 48 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 3 | 0 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 4 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 5 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 6 | 12 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 22: Clinical status 7 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 1 | 30 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 2 | 42 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 4 | 2 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 28: Clinical status 5 | 1 participants |
| Placebo and SOC | The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28 | Day 8 : Clinical status 2 | 37 participants |
Secondary
The Mortality Rate at Day 15
the number of patients with outcome of death in the 15 days following randomization
Time frame: Baseline to Day 15
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacritinib and SOC | The Mortality Rate at Day 15 | 5.1 % of patients with outcome of death /D15 |
| Placebo and SOC | The Mortality Rate at Day 15 | 4.0 % of patients with outcome of death /D15 |
p-value: 0.754195% CI: [0.31, 4.96]Cochran-Mantel-Haenszel
Secondary
The Mortality Rate at Day 28
the number of patients with outcome of death during the 28 days following randomization
Time frame: Baseline to Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacritinib and SOC | The Mortality Rate at Day 28 | 10.1 % of patients with outcome of death /D28 |
| Placebo and SOC | The Mortality Rate at Day 28 | 7.9 % of patients with outcome of death /D28 |
p-value: 0.632395% CI: [0.46, 3.58]Cochran-Mantel-Haenszel
Secondary
The Number of Ventilator-Free Days
the number of days that patients are alive and not intubated, from randomization to Day 28
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pacritinib and SOC | The Number of Ventilator-Free Days | 22.1 days | Standard Deviation 10.2 |
| Placebo and SOC | The Number of Ventilator-Free Days | 22.6 days | Standard Deviation 9.35 |
p-value: 0.7494Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pacritinib and SOC | The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19 | 97 Participants |
| Placebo and SOC | The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19 | 96 Participants |
p-value: 0.272295% CI: [0.47, 12.93]Chi-squared
Secondary
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.
Time frame: Baseline, Day 8, 15, 22, and 28.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pacritinib and SOC | The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status | 9.0 days |
| Placebo and SOC | The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status | 9.0 days |
p-value: 0.566695% CI: [0.79, 1.53]Log Rank