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| ID | Type | Description | Link |
|---|---|---|---|
| INCB 18424-368 | Other Identifier | Incyte Study Code | |
| 2020-001662-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
This was a Phase III, multicenter, double-blind, randomized, placebo-controlled study to assess the efficacy and safety of ruxolitinib in patients aged ≥12 years with COVID-19 disease. The study enrolled patients to ruxolitinib or placebo, in addition to standard of care (SoC) per local practice. Patients who meet the inclusion/exclusion criteria were randomized in a 2:1 ratio to either oral ruxolitinib 5 mg twice daily + SoC or oral matching-image placebo + SoC for a total of 14 days. An additional 14 days of study drug could be given if in the opinion of the investigator the patient's clinical signs and symptoms did not improve, or worsen, and the potential benefit outweighed the potential risk.
The study included:
The primary objective was to evaluate the efficacy (as measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 5 mg | Experimental | Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days |
|
| Placebo | Placebo Comparator | Matching-image placebo for 14 days with possible extension of treatment to 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib 5 mg tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care | 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. | Day 1 - Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status | Clinical status is measured with the 9-point ordinal scale. The scoring is:
|
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Inclusion Criteria:
Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.
Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).
Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.
Patients currently hospitalized or will be hospitalized prior to randomization.
Patients, who meet at least one of the below criteria:
Exclusion Criteria:
History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
Currently intubated or intubated between screening and randomization. In intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fullerton | California | 92835 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35368384 | Derived | Han MK, Antila M, Ficker JH, Gordeev I, Guerreros A, Bernus AL, Roquilly A, Sifuentes-Osornio J, Tabak F, Teijeiro R, Bandelli L, Bonagura DS, Shu X, Felser JM, Knorr B, Cao W, Langmuir P, Lehmann T, Levine M, Savic S. Ruxolitinib in addition to standard of care for the treatment of patients admitted to hospital with COVID-19 (RUXCOVID): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Rheumatol. 2022 May;4(5):e351-e361. doi: 10.1016/S2665-9913(22)00044-3. Epub 2022 Mar 29. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Patients were to be randomized on the same day as screening or up to 2 days after completing the screening procedures.
Participants took part in 61 investigative sites in 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib 5 mg | Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days |
| FG001 | Placebo | Matching-image placebo for 14 days with possible extension of treatment to 28 days |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2020 | Apr 15, 2021 |
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| Placebo | Drug | Matching-image placebo |
|
| Baseline, Day 15, Day 29 |
| Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status | 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. | Baseline, Day 15, Day 29 |
| Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status | 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. | Baseline, Day 15, Day 29 |
| Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status | 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. | Baseline, Day 15, Day 29 |
| Time to Improvement in Clinical Status | 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. | 29 days |
| Mean Change From Baseline in the Clinical Status | 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. | Baseline, Day 15, Day 29 |
| Mortality Rate | Mortality rate is determined as the proportion of participants who died by study Day 15 and Day 29 | Day 15, Day 29 |
| Proportion of Patients Requiring Mechanical Ventilation | 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. | Day 1 - Day 29 |
| Duration of Hospitalization | 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. | 29 days |
| Time to Hospital Discharge or to a NEWS2 Score of ≤2 | 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. | 29 days |
| Change From Baseline in NEWS2 Score | 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. | Baseline, Days 3, 5, 8, 11, 15, and 29 |
| Change From Baseline in SpO2/FiO2 Ratio | 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. | Baseline, Day 15, Day 29 |
| Proportion of Patients With no Oxygen Therapy | 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. | Day 15, Day 29 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Novartis Investigative Site | Denver | Colorado | 80205 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30312 | United States |
| Novartis Investigative Site | Idaho Falls | Idaho | 83404 | United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 | United States |
| Novartis Investigative Site | Newark | New Jersey | 07103 | United States |
| Novartis Investigative Site | The Bronx | New York | 10461 | United States |
| Novartis Investigative Site | Mesquite | Texas | 75149 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| Novartis Investigative Site | Madison | Wisconsin | 53705-3611 | United States |
| Novartis Investigative Site | C A B A | Buenos Aires | CP1405 | Argentina |
| Novartis Investigative Site | Buenos Aires | C1426AAM | Argentina |
| Novartis Investigative Site | Buenos Aires | C1430BKC | Argentina |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 22640-000 | Brazil |
| Novartis Investigative Site | Blumenau | Santa Catarina | 89030101 | Brazil |
| Novartis Investigative Site | Barretos | São Paulo | 14784 400 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01327 001 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04502 001 | Brazil |
| Novartis Investigative Site | Sorocaba | São Paulo | Brazil |
| Novartis Investigative Site | Rionegro | Antioquia | 054047 | Colombia |
| Novartis Investigative Site | Barranquilla | Atlántico | 080005 | Colombia |
| Novartis Investigative Site | Barranquilla | Colombia |
| Novartis Investigative Site | Colombes | 92701 | France |
| Novartis Investigative Site | Eaubonne | 95600 | France |
| Novartis Investigative Site | Nantes | 44093 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Lübeck | 23538 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Nuremberg | 90419 | Germany |
| Novartis Investigative Site | Mexico City | Mexico City | 14050 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico CP | 14080 | Mexico |
| Novartis Investigative Site | Estado de México | 52787 | Mexico |
| Novartis Investigative Site | San Isidro | Lima region | 27 | Peru |
| Novartis Investigative Site | San Miguel | Lima region | 32 | Peru |
| Novartis Investigative Site | Lima | 10 | Peru |
| Novartis Investigative Site | Lima | 1 | Peru |
| Novartis Investigative Site | Barnaul | 656045 | Russia |
| Novartis Investigative Site | Moscow | 111539 | Russia |
| Novartis Investigative Site | Moscow | 123056 | Russia |
| Novartis Investigative Site | Ryazan | 390039 | Russia |
| Novartis Investigative Site | S-Petersburg | 194354 | Russia |
| Novartis Investigative Site | Saint Petersburg | 193312 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Saint Petersburg | 199106 | Russia |
| Novartis Investigative Site | Sestroretsk | 197706 | Russia |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Badalona | Catalonia | 08916 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28031 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigative Site | Yenisehir/Izmir | 35110 | Turkey (Türkiye) |
| Novartis Investigative Site | Harrow | HA1 3UJ | United Kingdom |
| Novartis Investigative Site | Leeds | LS9 7TF | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| Novartis Investigative Site | London | WC1E 6HX | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9PL | United Kingdom |
|
| Safety Set | The Safety Set included all participants who received at least one dose of double-blind treatment. |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib 5 mg | Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days |
| BG001 | Placebo | Matching-image placebo for 14 days with possible extension of treatment to 28 days |
| BG002 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care | 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. | Randomized participants excluding those who developed respiratory failure and/or required ICU at randomization. | Posted | Count of Participants | Participants | Day 1 - Day 29 |
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| Secondary | Clinical Status | Clinical status is measured with the 9-point ordinal scale. The scoring is:
| Randomized participants with a valid assessment for the outcome measure. | Posted | Mean | Standard Deviation | score on scale | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status | 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. | Randomized participants with a valid assessment of clinical status at baseline. | Posted | Count of Participants | Participants | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status | 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. | Randomized participants with a valid assessment of clinical status at baseline. | Posted | Count of Participants | Participants | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status | 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. | Randomized participants with a valid assessment of clinical status at baseline. | Posted | Count of Participants | Participants | Baseline, Day 15, Day 29 |
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| Secondary | Time to Improvement in Clinical Status | 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. | Randomized participants with a valid assessment of clinical status at baseline. | Posted | Median | 95% Confidence Interval | days | 29 days |
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| Secondary | Mean Change From Baseline in the Clinical Status | 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. | Randomized participants with a valid assessment for the outcome measure. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline, Day 15, Day 29 |
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| Secondary | Mortality Rate | Mortality rate is determined as the proportion of participants who died by study Day 15 and Day 29 | All randomized participants including those who did not receive any dose, as per intent-to-treat principle, and excluding patients lost to follow up. | Posted | Count of Participants | Participants | Day 15, Day 29 |
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| Secondary | Proportion of Patients Requiring Mechanical Ventilation | 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. | Randomized participants with a valid assessment for the outcome measure. | Posted | Count of Participants | Participants | Day 1 - Day 29 |
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| Secondary | Duration of Hospitalization | 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. | Randomized participants with a valid assessment for the outcome measure. | Posted | Median | 95% Confidence Interval | days | 29 days |
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| Secondary | Time to Hospital Discharge or to a NEWS2 Score of ≤2 | 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. | Randomized participants with a valid assessment for the outcome measure. | Posted | Median | 95% Confidence Interval | days | 29 days |
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| Secondary | Change From Baseline in NEWS2 Score | 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. | Randomized participants with a valid assessment for the outcome measure. | Posted | Mean | Standard Deviation | score on scale | Baseline, Days 3, 5, 8, 11, 15, and 29 |
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| Secondary | Change From Baseline in SpO2/FiO2 Ratio | 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. | Randomized participants with a valid assessment of the outcome measure. | Posted | Mean | Standard Deviation | no units | Baseline, Day 15, Day 29 |
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| Secondary | Proportion of Patients With no Oxygen Therapy | 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. | Randomized participants with a valid assessment of the outcome measure. | Posted | Count of Participants | Participants | Day 15, Day 29 |
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| Post-Hoc | All Collected Deaths | 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. | Clinical database population - all randomized participants | Posted | Number | participants | 29 days |
|
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From first dose of double-blind treatment and up to the last study visit (Day 29).
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.
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 5 mg | Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days | 9 | 281 | 31 | 281 | 113 | 281 |
| EG001 | Placebo | Matching-image placebo for 14 days with possible extension of treatment to 28 days | 3 | 143 | 15 | 143 | 62 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Adams-Stokes syndrome | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Adverse event | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Antibiotic associated colitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2020 | Apr 15, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000080424 | Cytokine Release Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
Not provided
Not provided
Not provided
| Male |
|
| American Indian Or Alaska Native |
|
| Black Or African American |
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| Asian |
|
| Multiple |
|
| Unknown |
|
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| Participants |
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