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Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362137
Recruitment Status : Completed
First Posted : April 24, 2020
Results First Posted : June 2, 2021
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cytokine Storm (Covid-19)
Interventions Drug: Ruxolitinib
Drug: Placebo
Enrollment 432
Recruitment Details Participants took part in 61 investigative sites in 12 countries.
Pre-assignment Details Patients were to be randomized on the same day as screening or up to 2 days after completing the screening procedures.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days Matching-image placebo for 14 days with possible extension of treatment to 28 days
Period Title: Overall Study
Started [1] 287 145
Safety Set [2] 281 143
Completed 269 139
Not Completed 18 6
Reason Not Completed
Death             9             3
Patient decision             6             3
Adverse Event             1             0
Lost to Follow-up             1             0
Protocol deviation             1             0
[1]
Randomized participants.
[2]
The Safety Set included all participants who received at least one dose of double-blind treatment.
Arm/Group Title Ruxolitinib 5 mg Placebo Total
Hide Arm/Group Description Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days Matching-image placebo for 14 days with possible extension of treatment to 28 days Total of all reporting groups
Overall Number of Baseline Participants 287 145 432
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 287 participants 145 participants 432 participants
56.4  (13.7) 56.9  (12.5) 56.5  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 145 participants 432 participants
Female
125
  43.6%
72
  49.7%
197
  45.6%
Male
162
  56.4%
73
  50.3%
235
  54.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 145 participants 432 participants
White
242
  84.3%
109
  75.2%
351
  81.3%
American Indian Or Alaska Native
26
   9.1%
13
   9.0%
39
   9.0%
Black Or African American
6
   2.1%
9
   6.2%
15
   3.5%
Asian
5
   1.7%
5
   3.4%
10
   2.3%
Multiple
3
   1.0%
2
   1.4%
5
   1.2%
Unknown
5
   1.7%
7
   4.8%
12
   2.8%
1.Primary Outcome
Title Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care
Hide Description Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care for the treatment of COVID-19. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who developed respiratory failure and/or required ICU at randomization are excluded from the analysis.
Time Frame Day 1 - Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants excluding those who developed respiratory failure and/or required ICU at randomization.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 284 144
Measure Type: Count of Participants
Unit of Measure: Participants
34
  12.0%
17
  11.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.48 to 1.73
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio < 1 favors the ruxolitinib 5 mg arm
2.Secondary Outcome
Title Clinical Status
Hide Description

Clinical status is measured with the 9-point ordinal scale.

The scoring is:

  • Uninfected patients have a score 0 (no clinical or virological evidence of infection).
  • Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities).
  • Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as peripheral oxygen saturation (SpO2) ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs).
  • Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)).
  • Patients who die have a score 8.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment for the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 286 participants 145 participants
3.7  (0.56) 3.7  (0.53)
Day 15 Number Analyzed 280 participants 142 participants
1.8  (1.54) 1.8  (1.41)
Day 29 Number Analyzed 278 participants 142 participants
1.1  (1.61) 1.0  (1.41)
3.Secondary Outcome
Title Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status
Hide Description Percentage of patients with at least two points improvement in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment of clinical status at baseline.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 15
206
  72.0%
108
  74.5%
Day 29
252
  88.1%
129
  89.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.647
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.55 to 1.46
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio > 1 favors the ruxolitinib 5 mg arm
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 29
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.52 to 1.92
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio > 1 favors the ruxolitinib 5 mg arm
4.Secondary Outcome
Title Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status
Hide Description Percentage of patients with at least one point improvement in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment of clinical status at baseline.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 15
250
  87.4%
128
  88.3%
Day 29
261
  91.3%
136
  93.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.946
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.51 to 1.87
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio > 1 favors the ruxolitinib 5 mg arm
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 29
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.573
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.35 to 1.79
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio > 1 favors the ruxolitinib 5 mg arm
5.Secondary Outcome
Title Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status
Hide Description Percentage of patients with at least one point deterioration in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment of clinical status at baseline.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 15
16
   5.6%
9
   6.2%
Day 29
14
   4.9%
5
   3.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.532
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.31 to 1.83
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio < 1 favors the ruxolitinib 5 mg arm
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 29
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.764
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.40 to 3.49
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio < 1 favors the ruxolitinib 5 mg arm
6.Secondary Outcome
Title Time to Improvement in Clinical Status
Hide Description

Time to improvement in clinical status from baseline category to one less severe category of the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment.

Median time to improvement is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study. Patients who did not achieve improvement and did not die are censored at their last clinical status assessment date.

Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment of clinical status at baseline.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Median (95% Confidence Interval)
Unit of Measure: days
9.0
(8.0 to 10.0)
9.0
(8.0 to 12.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments [Not Specified]
Method Proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.90 to 1.37
Estimation Comments Between group comparison using competing risk framework. A hazard ratio > 1 favors the ruxolitinib 5 mg arm
7.Secondary Outcome
Title Mean Change From Baseline in the Clinical Status
Hide Description

Mean change from baseline in the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are excluded from the analysis.

A negative change from baseline in the clinical status is a favorable outcome.

Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment for the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Day 15 Number Analyzed 280 participants 142 participants
-1.96  (0.084) -1.93  (0.118)
Day 29 Number Analyzed 278 participants 142 participants
-2.61  (0.090) -2.69  (0.126)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.831
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares (LS) mean
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.31 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.144
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 29
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.23 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.155
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mortality Rate
Hide Description Mortality rate is determined as the proportion of participants who died by study Day 15 and Day 29
Time Frame Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants including those who did not receive any dose, as per intent-to-treat principle, and excluding patients lost to follow up.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 15 Number Analyzed 286 participants 145 participants
6
   2.1%
2
   1.4%
Day 29 Number Analyzed 286 participants 145 participants
9
   3.1%
3
   2.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.20 to 5.57
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio < 1 favors the ruxolitinib 5 mg arm
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 29
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.775
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.35 to 5.11
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio < 1 favors the ruxolitinib 5 mg arm
9.Secondary Outcome
Title Proportion of Patients Requiring Mechanical Ventilation
Hide Description Proportion of patients requiring mechanical ventilation. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who required mechanical ventilation at randomization are excluded from the analysis.
Time Frame Day 1 - Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment for the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Measure Type: Count of Participants
Unit of Measure: Participants
22
   7.7%
10
   6.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.45 to 2.21
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio < 1 favors the ruxolitinib 5 mg arm
10.Secondary Outcome
Title Duration of Hospitalization
Hide Description Duration of hospitalization is defined as time to hospital discharge. Median time to hospital discharge is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study. Patients who were not discharged and did not die are censored at their last assessment date.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment for the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Median (95% Confidence Interval)
Unit of Measure: days
9.0
(8.0 to 10.0)
9.0
(8.0 to 12.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments [Not Specified]
Method Proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.84 to 1.28
Estimation Comments Between group comparison using competing risk framework. A hazard ratio > 1 favors the ruxolitinib 5 mg arm
11.Secondary Outcome
Title Time to Hospital Discharge or to a NEWS2 Score of ≤2
Hide Description

The time to hospital discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours whichever comes first.

The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst).

Median time is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study.

Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment for the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 286 145
Median (95% Confidence Interval)
Unit of Measure: days
4.0
(3.0 to 4.0)
4.0
(3.0 to 5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.869
Comments [Not Specified]
Method Proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.84 to 1.23
Estimation Comments Between group comparison using competing risk framework. A hazard ratio > 1 favors the ruxolitinib 5 mg arm
12.Secondary Outcome
Title Change From Baseline in NEWS2 Score
Hide Description

The National Early Warning Score 2 (NEWS2) is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst). At each visit, only patients with a value at both baseline and the respective visit are included.

A negative change from baseline in NEWS2 score is a favorable outcome.

Time Frame Baseline, Days 3, 5, 8, 11, 15, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment for the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Mean (Standard Deviation)
Unit of Measure: score on scale
Day 3 Number Analyzed 264 participants 135 participants
-0.7  (1.91) -0.6  (2.13)
Day 5 Number Analyzed 230 participants 120 participants
-1.0  (2.02) -0.8  (2.19)
Day 8 Number Analyzed 175 participants 91 participants
-1.3  (2.25) -1.3  (2.60)
Day 11 Number Analyzed 113 participants 66 participants
-1.1  (2.70) -1.3  (2.74)
Day 15 Number Analyzed 257 participants 132 participants
-1.9  (2.34) -2.2  (2.35)
Day 29 Number Analyzed 234 participants 122 participants
-2.3  (2.37) -2.5  (2.17)
13.Secondary Outcome
Title Change From Baseline in SpO2/FiO2 Ratio
Hide Description

Change from baseline in peripheral oxygen saturation / fraction of inspired oxygen ratio (SpO2/FiO2 ratio). At each visit, only patients with a value at both baseline and the respective visit are included.

A positive change from baseline in SpO2/FiO2 ratio is a favorable outcome.

Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment of the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Mean (Standard Deviation)
Unit of Measure: no units
Day 15 Number Analyzed 260 participants 132 participants
90.110  (104.4783) 106.766  (100.9778)
Day 29 Number Analyzed 232 participants 124 participants
105.553  (98.2452) 109.710  (95.4279)
14.Secondary Outcome
Title Proportion of Patients With no Oxygen Therapy
Hide Description

Proportion of patients with no oxygen therapy (defined as oxygen saturation ≥ 94% on room air) at Days 15 and 29. Analyses are cumulative, thus analysis on each day includes all events till that day.

Patients with missing data at Day 15 and/or Day 29 are excluded from the analysis.

Time Frame Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a valid assessment of the outcome measure.
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Measure Type: Count of Participants
Unit of Measure: Participants
Day 15 Number Analyzed 274 participants 140 participants
255
  93.1%
133
  95.0%
Day 29 Number Analyzed 269 participants 139 participants
262
  97.4%
136
  97.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 15
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.23 to 1.63
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio > 1 favors the ruxolitinib 5 mg arm
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5 mg, Placebo
Comments Day 29
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments P-value was not estimable because >97% patients fall into one category (responders) in both groups, and very few patients fall into the other one (non-responders), which made the logistic regression model fail to converge even with Firth's correction
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.25 to 5.40
Estimation Comments Comparison is ruxolitinib 5 mg/placebo. An odds ratio > 1 favors the ruxolitinib 5 mg arm
15.Post-Hoc Outcome
Title All Collected Deaths
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Deaths in the safety population were evaluated in all participants who received at least one dose of double-blind treatment.

Total deaths were evaluated in all participants randomized.

Time Frame 29 days
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Hide Analysis Population Description
Clinical database population - all randomized participants
Arm/Group Title Ruxolitinib 5 mg Placebo
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Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Matching-image placebo for 14 days with possible extension of treatment to 28 days
Overall Number of Participants Analyzed 287 145
Measure Type: Number
Unit of Measure: participants
Deaths in the safety population Number Analyzed 281 participants 143 participants
9 3
Total deaths Number Analyzed 287 participants 145 participants
9 3
Time Frame From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse Event Reporting Description

Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29).

Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.

 
Arm/Group Title Ruxolitinib 5 mg Placebo
Hide Arm/Group Description Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days Matching-image placebo for 14 days with possible extension of treatment to 28 days
All-Cause Mortality
Ruxolitinib 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/281 (3.20%)   3/143 (2.10%) 
Hide Serious Adverse Events
Ruxolitinib 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   31/281 (11.03%)   15/143 (10.49%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1  1/281 (0.36%)  0/143 (0.00%) 
Cardiac disorders     
Adams-Stokes syndrome  1  1/281 (0.36%)  0/143 (0.00%) 
Atrial fibrillation  1  1/281 (0.36%)  0/143 (0.00%) 
Cardiac arrest  1  1/281 (0.36%)  0/143 (0.00%) 
Cardiopulmonary failure  1  0/281 (0.00%)  1/143 (0.70%) 
Ear and labyrinth disorders     
Vertigo  1  0/281 (0.00%)  1/143 (0.70%) 
Gastrointestinal disorders     
Pancreatitis  1  1/281 (0.36%)  0/143 (0.00%) 
General disorders     
Adverse event  1  1/281 (0.36%)  0/143 (0.00%) 
General physical health deterioration  1  1/281 (0.36%)  0/143 (0.00%) 
Multiple organ dysfunction syndrome  1  1/281 (0.36%)  1/143 (0.70%) 
Performance status decreased  1  1/281 (0.36%)  0/143 (0.00%) 
Infections and infestations     
Antibiotic associated colitis  1  1/281 (0.36%)  0/143 (0.00%) 
Bacteraemia  1  1/281 (0.36%)  0/143 (0.00%) 
COVID-19  1  8/281 (2.85%)  3/143 (2.10%) 
COVID-19 pneumonia  1  1/281 (0.36%)  0/143 (0.00%) 
Escherichia bacteraemia  1  0/281 (0.00%)  1/143 (0.70%) 
Pneumonia  1  3/281 (1.07%)  0/143 (0.00%) 
Pneumonia fungal  1  1/281 (0.36%)  0/143 (0.00%) 
Urinary tract infection  1  0/281 (0.00%)  1/143 (0.70%) 
Injury, poisoning and procedural complications     
Endotracheal intubation complication  1  1/281 (0.36%)  0/143 (0.00%) 
Fall  1  0/281 (0.00%)  1/143 (0.70%) 
Investigations     
Alanine aminotransferase increased  1  0/281 (0.00%)  1/143 (0.70%) 
Transaminases increased  1  0/281 (0.00%)  1/143 (0.70%) 
Nervous system disorders     
Cerebral infarction  1  1/281 (0.36%)  0/143 (0.00%) 
Hypoglycaemic coma  1  1/281 (0.36%)  0/143 (0.00%) 
Ischaemic stroke  1  1/281 (0.36%)  0/143 (0.00%) 
Psychiatric disorders     
Mental status changes  1  1/281 (0.36%)  0/143 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/281 (0.36%)  1/143 (0.70%) 
Acute respiratory failure  1  4/281 (1.42%)  1/143 (0.70%) 
Dyspnoea  1  1/281 (0.36%)  0/143 (0.00%) 
Hypoxia  1  4/281 (1.42%)  4/143 (2.80%) 
Pneumothorax  1  1/281 (0.36%)  0/143 (0.00%) 
Pulmonary fibrosis  1  1/281 (0.36%)  0/143 (0.00%) 
Respiratory disorder  1  1/281 (0.36%)  0/143 (0.00%) 
Respiratory distress  1  1/281 (0.36%)  0/143 (0.00%) 
Respiratory failure  1  2/281 (0.71%)  2/143 (1.40%) 
Vascular disorders     
Deep vein thrombosis  1  1/281 (0.36%)  0/143 (0.00%) 
Shock  1  1/281 (0.36%)  0/143 (0.00%) 
1
Term from vocabulary, MedDRA (23.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ruxolitinib 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   113/281 (40.21%)   62/143 (43.36%) 
Blood and lymphatic system disorders     
Leukocytosis  1  4/281 (1.42%)  4/143 (2.80%) 
Neutropenia  1  6/281 (2.14%)  4/143 (2.80%) 
Thrombocytosis  1  6/281 (2.14%)  3/143 (2.10%) 
Gastrointestinal disorders     
Abdominal pain  1  4/281 (1.42%)  4/143 (2.80%) 
Constipation  1  9/281 (3.20%)  7/143 (4.90%) 
Diarrhoea  1  21/281 (7.47%)  12/143 (8.39%) 
Nausea  1  6/281 (2.14%)  11/143 (7.69%) 
General disorders     
Asthenia  1  6/281 (2.14%)  0/143 (0.00%) 
Fatigue  1  10/281 (3.56%)  2/143 (1.40%) 
Pyrexia  1  6/281 (2.14%)  2/143 (1.40%) 
Infections and infestations     
Urinary tract infection  1  3/281 (1.07%)  4/143 (2.80%) 
Investigations     
Alanine aminotransferase increased  1  17/281 (6.05%)  6/143 (4.20%) 
Aspartate aminotransferase increased  1  5/281 (1.78%)  3/143 (2.10%) 
Transaminases increased  1  7/281 (2.49%)  2/143 (1.40%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  4/281 (1.42%)  5/143 (3.50%) 
Hyperkalaemia  1  6/281 (2.14%)  6/143 (4.20%) 
Hypokalaemia  1  8/281 (2.85%)  7/143 (4.90%) 
Hyponatraemia  1  1/281 (0.36%)  3/143 (2.10%) 
Hypoproteinaemia  1  4/281 (1.42%)  3/143 (2.10%) 
Nervous system disorders     
Dizziness  1  2/281 (0.71%)  4/143 (2.80%) 
Headache  1  23/281 (8.19%)  11/143 (7.69%) 
Psychiatric disorders     
Anxiety  1  6/281 (2.14%)  1/143 (0.70%) 
Insomnia  1  3/281 (1.07%)  4/143 (2.80%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  12/281 (4.27%)  3/143 (2.10%) 
Dyspnoea  1  3/281 (1.07%)  3/143 (2.10%) 
Vascular disorders     
Hypertension  1  4/281 (1.42%)  3/143 (2.10%) 
1
Term from vocabulary, MedDRA (23.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT04362137    
Other Study ID Numbers: CINC424J12301
INCB 18424-368 ( Other Identifier: Incyte Study Code )
2020-001662-11 ( EudraCT Number )
First Submitted: April 22, 2020
First Posted: April 24, 2020
Results First Submitted: April 15, 2021
Results First Posted: June 2, 2021
Last Update Posted: October 11, 2021