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Study terminated by sponsor
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Standard of Care (SoC) | Placebo Comparator | Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. |
|
| Ruxolitinib 5mg + Standard of Care (SoC) | Experimental | Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. |
|
| Ruxolitininb 15mg + Standard of Care (SoC) | Experimental | Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo administered BID approximately 12 hours apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study start to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ventilator Free Days | Number of days participant did not require mechanical ventilation | Study start to Day 29 |
| Number of ICU Free Days | Number of days participant is out of the ICU |
Not provided
Inclusion Criteria:
Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Sharp Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36226977 | Derived | Rein L, Calero K, Shah R, Ojielo C, Hudock KM, Lodhi S, Sadaka F, Bellam S, Palma C, Hager DN, Daniel J, Schaub R, O'Hayer K, Theodoropoulos NM. Randomized Phase 3 Trial of Ruxolitinib for COVID-19-Associated Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Dec 1;50(12):1701-1713. doi: 10.1097/CCM.0000000000005682. Epub 2022 Oct 13. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitininb 15mg + Standard of Care | Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. |
| FG001 | Ruxolitinib 5mg + Standard of Care (SoC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2020 | Nov 17, 2021 |
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Double blinded
| Ruxolitinib |
| Drug |
Ruxolitinb administered BID approximately 12 hours apart |
|
|
| Study start to Day 29 |
| Oxygen Free Days | Number of days participant did not receive supplemental oxygen | Study start to Day 29 |
| Vasopressor Free Days | Number of days without use of vasopressor therapy | Study start to Day 29 |
| Hospital Free Days | Number of days Partcipant is out of the hospital | Study start to Day 29 |
| 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 | Study start to Days 15 and 29 |
| 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 | Study start to Days 15 and 29 |
| 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 | Study Start to Day 29 |
| 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 | Study start to Day 29 |
| 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 | Study start to Days 15 and 29 |
| 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). | from baseline to Days 3, 5, 8, 11, 15, and 29 |
| 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. | Study start to Day 29 |
| San Diego |
| California |
| 92123 |
| United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Teradan Clinical Trials | Brandon | Florida | 33511 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Northshore University Health System | Chicago | Illinois | 60678 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health Central Indiana Cancer Centers | Indianapolis | Indiana | 46219 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Healthpartners Cancer Care Center - Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Mercy Research | Springfield | Missouri | 65804 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Njms Clinical Research Unit | Newark | New Jersey | 07103 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Kettering Cancer Care | Dayton | Ohio | 45429 | United States |
| Jefferson University Hospitals | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Allegheny Health Network | Wexford | Pennsylvania | 15090 | United States |
| St David'S Medical Center | Austin | Texas | 78705 | United States |
| University of Texas Health Science Center At Houston - McGovern Medical School | Houston | Texas | 77030 | United States |
| University of Texas Health Science Cente | San Antonio | Texas | 78229 | United States |
| Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | 98801 | United States |
| Aurora Research Institute | Milwaukee | Wisconsin | 53233 | United States |
| Sbih City Hospital 15 | Saint Petersburg | 198205 | Russia |
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who were randomized to the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Percentage | Study start to Day 29 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Ventilator Free Days | Number of days participant did not require mechanical ventilation | 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. | Posted | Mean | Standard Deviation | Days | Study start to Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of ICU Free Days | Number of days participant is out of the ICU | 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. | Posted | Mean | Standard Deviation | Days | Study start to Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Oxygen Free Days | Number of days participant did not receive supplemental oxygen | 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. | Posted | Mean | Standard Deviation | Days | Study start to Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vasopressor Free Days | Number of days without use of vasopressor therapy | 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. | Posted | Mean | Standard Deviation | Days | Study start to Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Free Days | Number of days Partcipant is out of the hospital | 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. | Posted | Mean | Standard Deviation | Days | Study start to Day 29 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Study start to Days 15 and 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Study start to Days 15 and 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Median | 95% Confidence Interval | Days | Study Start to Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | Percentage | Study start to Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | Score on a Scale | Study start to Days 15 and 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | from baseline to Days 3, 5, 8, 11, 15, and 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The safety population includes all participants who received at least 1 dose of ruxolitinib/placebo. | Posted | Count of Participants | Participants | Study start to Day 29 |
|
|
Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib 15 mg BID | Ruxolitinib 15 mg BID | 42 | 77 | 23 | 77 | 35 | 77 |
| EG001 | Ruxolitinib 5 mg BID | Ruxolitinib 5 mg BID | 48 | 87 | 21 | 87 | 46 | 87 |
| EG002 | Placebo | Placebo | 36 | 47 | 11 | 45 | 21 | 45 |
| EG003 | Total | Total | 124 | 209 | 55 | 209 | 102 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 22 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 22 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Strongyloidiasis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2021 | Nov 17, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D000075242 | Janus Kinase Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect. |
| 0.0280 |
| Odds Ratio (OR) |
| 0.42 |
| 2-Sided |
| 95 |
| 0.171 |
| 1.023 |
| Superiority |
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| 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. |
|
|
| Counts |
|---|
| Participants |
|
|