COVID-19
Conditions
Keywords
Cytokine storm, COVID-19, ARDS, SARS-CoV-2, ruxolitinib, pneumonia
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
Interventions
DRUGPlacebo
Placebo administered BID approximately 12 hours apart
DRUGRuxolitinib
Ruxolitinb administered BID approximately 12 hours apart
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant or guardian health proxy must provide informed consent before any study assessment is performed. * Male or female participants aged ≥ 12 years. * Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval. * Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization. Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.
Exclusion criteria
* Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib. * Presence of severely impaired renal function defined by estimated creatinine clearance \< 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening. * In the opinion of the investigator, unlikely to survive for \> 24 hours from randomization. * Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19). * Currently receiving ECMO. * Participant may not be sharing a ventilator, or co-ventilating, with any other patient. * Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization. * Treatment with a JAK inhibitor within 30 days of randomization. * Participants who are on long-term use of antirejection or immunomodulatory drugs. * Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Have Died Due to Any Cause | Study start to Day 29 | To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ICU Free Days | Study start to Day 29 | Number of days participant is out of the ICU |
| Oxygen Free Days | Study start to Day 29 | Number of days participant did not receive supplemental oxygen |
| Vasopressor Free Days | Study start to Day 29 | Number of days without use of vasopressor therapy |
| Hospital Free Days | Study start to Day 29 | Number of days Partcipant is out of the hospital |
| Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Study start to Days 15 and 29 | Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead |
| Number of Ventilator Free Days | Study start to Day 29 | Number of days participant did not require mechanical ventilation |
| Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale | Study Start to Day 29 | TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead |
| Percentage of Participants With the COVID-19 Ordinal Scale Reported | Study start to Day 29 | Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead |
| Change in the COVID-19 9-point Ordinal Scale | Study start to Days 15 and 29 | Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead |
| Change in SOFA Score | from baseline to Days 3, 5, 8, 11, 15, and 29 | Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality). |
| Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Study start to Day 29 | Treatment-emergent AEs are judged as related by the investigator or have a missing causality. |
| Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Study start to Days 15 and 29 | Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead |
Countries
Russia, United States
Participant flow
Recruitment details
This study was conducted at 33 study centers in the United States (29) and Russia (4), and 211 participants were enrolled and analyzed for efficacy.; 209 participants were analyzed for safety. Enrollment in this study was stopped early and was not due to safety reasons.
Pre-assignment details
Participants were randomly assigned in a 2:2:1 ratio to receive ruxolitinib 5 mg BID, ruxolitinib 15 mg BID, or placebo for an initial treatment period of 14 days; participants randomly assigned to receive placebo were randomly assigned in a 1:1 ratio to receive placebo matching ruxolitinib 5 mg BID or placebo matching ruxolitinib 15 mg BID. Randomization was stratified by ARDS severity (severe vs mild/moderate at the time of randomization) and investigative site.
Participants by arm
| Arm | Count |
|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. | 77 |
| Ruxolitinib 5mg + Standard of Care (SoC) Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. | 87 |
| Placebo + Standard of Care (SoC) Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. | 47 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 42 | 48 | 36 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Ruxolitininb 15mg + Standard of Care (SoC) | Ruxolitinib 5mg + Standard of Care (SoC) | Placebo + Standard of Care (SoC) | Total |
|---|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 12.92 | 63.6 Years STANDARD_DEVIATION 12.25 | 62.5 Years STANDARD_DEVIATION 13.34 | 63.4 Years STANDARD_DEVIATION 12.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 21 Participants | 12 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 64 Participants | 34 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 12 Participants | 5 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 11 Participants | 8 Participants | 27 Participants |
| Race (NIH/OMB) White | 57 Participants | 61 Participants | 31 Participants | 149 Participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 13 Participants | 74 Participants |
| Sex: Female, Male Male | 48 Participants | 55 Participants | 34 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 42 / 77 | 48 / 87 | 36 / 47 | 124 / 209 |
| other Total, other adverse events | 35 / 77 | 46 / 87 | 21 / 45 | 102 / 209 |
| serious Total, serious adverse events | 23 / 77 | 21 / 87 | 11 / 45 | 55 / 209 |
Outcome results
Primary
Percentage of Participants Who Have Died Due to Any Cause
To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants Who Have Died Due to Any Cause | 50.6 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants Who Have Died Due to Any Cause | 52.9 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants Who Have Died Due to Any Cause | 70.2 Percentage |
p-value: 0.029295% CI: [0.201, 1.028]Mixed Models Analysis
p-value: 0.02895% CI: [0.171, 1.023]Mixed Models Analysis
Secondary
Change in SOFA Score
Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).
Time frame: from baseline to Days 3, 5, 8, 11, 15, and 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Numbers of participants decreased after Day 1 because data was no longer collected if a patient was discharged from ICU and/or deceased.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Day 5 | 0.2 Scores on a Scale | Standard Deviation 4.27 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Day 29 | 10.3 Scores on a Scale | Standard Deviation 8.54 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Day 11 | 2.5 Scores on a Scale | Standard Deviation 7.64 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Day 8 | 1.9 Scores on a Scale | Standard Deviation 6.77 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Day 3 | -0.1 Scores on a Scale | Standard Deviation 2.77 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Baseline - Day 1 | 9.2 Scores on a Scale | Standard Deviation 2.35 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in SOFA Score | Day 15 | 4.2 Scores on a Scale | Standard Deviation 9.24 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Day 8 | 2.0 Scores on a Scale | Standard Deviation 6.3 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Baseline - Day 1 | 9.6 Scores on a Scale | Standard Deviation 2.53 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Day 3 | 0.4 Scores on a Scale | Standard Deviation 3.14 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Day 5 | 0.7 Scores on a Scale | Standard Deviation 4.58 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Day 11 | 2.0 Scores on a Scale | Standard Deviation 7.02 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Day 15 | 4.1 Scores on a Scale | Standard Deviation 7.72 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in SOFA Score | Day 29 | 10.4 Scores on a Scale | Standard Deviation 7.04 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Day 11 | 6.5 Scores on a Scale | Standard Deviation 8.26 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Day 3 | 2.6 Scores on a Scale | Standard Deviation 5.89 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Day 29 | 12.8 Scores on a Scale | Standard Deviation 5.41 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Day 15 | 10.3 Scores on a Scale | Standard Deviation 7.89 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Day 8 | 4.5 Scores on a Scale | Standard Deviation 7.87 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Day 5 | 3.3 Scores on a Scale | Standard Deviation 6.6 |
| Placebo + Standard of Care (SoC) | Change in SOFA Score | Baseline - Day 1 | 9.4 Scores on a Scale | Standard Deviation 2.69 |
Secondary
Change in the COVID-19 9-point Ordinal Scale
Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time frame: Study start to Days 15 and 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. In the 15mg BID arm, 3 participants were missing scale reportingon Day 29. IN the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in the COVID-19 9-point Ordinal Scale | Change from Day 1 to Day 15 | -0.4 Score on a Scale | Standard Deviation 1.8 |
| Ruxolitininb 15mg + Standard of Care (SoC) | Change in the COVID-19 9-point Ordinal Scale | Change from Day 1 to Day 29 | -0.5 Score on a Scale | Standard Deviation 2.53 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in the COVID-19 9-point Ordinal Scale | Change from Day 1 to Day 15 | -0.2 Score on a Scale | Standard Deviation 1.73 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Change in the COVID-19 9-point Ordinal Scale | Change from Day 1 to Day 29 | -0.4 Score on a Scale | Standard Deviation 2.57 |
| Placebo + Standard of Care (SoC) | Change in the COVID-19 9-point Ordinal Scale | Change from Day 1 to Day 15 | 0.6 Score on a Scale | Standard Deviation 1.69 |
| Placebo + Standard of Care (SoC) | Change in the COVID-19 9-point Ordinal Scale | Change from Day 1 to Day 29 | 0.4 Score on a Scale | Standard Deviation 2.23 |
Secondary
Hospital Free Days
Number of days Partcipant is out of the hospital
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Hospital Free Days | 2.09 Days | Standard Deviation 4.889 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Hospital Free Days | 2.35 Days | Standard Deviation 5.259 |
| Placebo + Standard of Care (SoC) | Hospital Free Days | 1.38 Days | Standard Deviation 3.976 |
Secondary
Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events
Treatment-emergent AEs are judged as related by the investigator or have a missing causality.
Time frame: Study start to Day 29
Population: The safety population includes all participants who received at least 1 dose of ruxolitinib/placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Serious TEAEs | 23 Participants |
| Ruxolitininb 15mg + Standard of Care (SoC) | Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 22 Participants |
| Ruxolitinib 5mg + Standard of Care (SoC) | Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 23 Participants |
| Ruxolitinib 5mg + Standard of Care (SoC) | Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Serious TEAEs | 21 Participants |
| Placebo + Standard of Care (SoC) | Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 11 Participants |
| Placebo + Standard of Care (SoC) | Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events | Serious TEAEs | 11 Participants |
Secondary
Number of ICU Free Days
Number of days participant is out of the ICU
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Number of ICU Free Days | 4.75 Days | Standard Deviation 7.716 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Number of ICU Free Days | 4.00 Days | Standard Deviation 7.517 |
| Placebo + Standard of Care (SoC) | Number of ICU Free Days | 2.45 Days | Standard Deviation 6.362 |
Secondary
Number of Ventilator Free Days
Number of days participant did not require mechanical ventilation
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Number of Ventilator Free Days | 6.31 Days | Standard Deviation 9.047 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Number of Ventilator Free Days | 4.92 Days | Standard Deviation 8.398 |
| Placebo + Standard of Care (SoC) | Number of Ventilator Free Days | 2.98 Days | Standard Deviation 7.228 |
Secondary
Oxygen Free Days
Number of days participant did not receive supplemental oxygen
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Oxygen Free Days | 2.66 Days | Standard Deviation 6.073 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Oxygen Free Days | 2.98 Days | Standard Deviation 6.745 |
| Placebo + Standard of Care (SoC) | Oxygen Free Days | 1.53 Days | Standard Deviation 4.69 |
Secondary
Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale
Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time frame: Study start to Days 15 and 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Day 15 | 41.6 Percentage of Participants |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Day 29 | 43.2 Percentage of Participants |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Day 15 | 32.9 Percentage of Participants |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Day 29 | 32.5 Percentage of Participants |
| Placebo + Standard of Care (SoC) | Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Day 15 | 21.3 Percentage of Participants |
| Placebo + Standard of Care (SoC) | Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale | Day 29 | 17.0 Percentage of Participants |
Secondary
Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale
Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time frame: Study start to Days 15 and 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Day 15 | 22.1 Percentage of Participants |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Day 29 | 29.7 Percentage of Participants |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Day 15 | 15.3 Percentage of Participants |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Day 29 | 25.3 Percentage of Participants |
| Placebo + Standard of Care (SoC) | Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Day 15 | 10.6 Percentage of Participants |
| Placebo + Standard of Care (SoC) | Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale | Day 29 | 17.0 Percentage of Participants |
Secondary
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Please note that in the 15mg BID arm, 3 participants were missing scale reporting on Day 29. In the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 3 = Hospitalized/Mild Disease (no oxygen therapy) | 0 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 8 - Death | 50.6 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen) | 3.9 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs) | 9.1 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 0 = Uninfected | 0 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support) | 2.6 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 2 = Ambulatory (limitation of activities) | 16.9 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 1 = Ambulatory (no limitation of activities) | 2.6 Percentage |
| Ruxolitininb 15mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization) | 10.4 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs) | 1.1 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 0 = Uninfected | 4.6 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 1 = Ambulatory (no limitation of activities) | 0 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 2 = Ambulatory (limitation of activities) | 16.1 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 3 = Hospitalized/Mild Disease (no oxygen therapy) | 1.1 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen) | 4.6 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization) | 8.0 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support) | 8.0 Percentage |
| Ruxolitinib 5mg + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 8 - Death | 51.7 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 2 = Ambulatory (limitation of activities) | 10.6 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 0 = Uninfected | 0 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization) | 2.1 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 1 = Ambulatory (no limitation of activities) | 2.1 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 8 - Death | 70.2 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs) | 4.3 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 3 = Hospitalized/Mild Disease (no oxygen therapy) | 0 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support) | 10.6 Percentage |
| Placebo + Standard of Care (SoC) | Percentage of Participants With the COVID-19 Ordinal Scale Reported | Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen) | 0.0 Percentage |
Secondary
Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale
TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time frame: Study Start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale | 0.91 Days |
| Ruxolitinib 5mg + Standard of Care (SoC) | Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale | 0.75 Days |
| Placebo + Standard of Care (SoC) | Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale | 0.61 Days |
Secondary
Vasopressor Free Days
Number of days without use of vasopressor therapy
Time frame: Study start to Day 29
Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitininb 15mg + Standard of Care (SoC) | Vasopressor Free Days | 8.95 Days | Standard Deviation 11.738 |
| Ruxolitinib 5mg + Standard of Care (SoC) | Vasopressor Free Days | 7.53 Days | Standard Deviation 10.861 |
| Placebo + Standard of Care (SoC) | Vasopressor Free Days | 4.47 Days | Standard Deviation 9.322 |