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RuxolitinibWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug570 Observation of behavior and COVID-19 infection will be conducted. Wiki 0.45
drug357 Humanistic Care Wiki 0.45
drug608 Peripheral blood draw Wiki 0.45
drug1014 recombinant human interferon Alpha-1b Wiki 0.45
drug164 CT-V Wiki 0.45
drug1036 thymosin alpha 1 Wiki 0.45
drug616 Placebo Wiki 0.05

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.13
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D011014 Pneumonia NIH 0.04

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.07

There are 5 clinical trials

Clinical Trials


1 Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. Please refer to the latest Investigator's Brochure (IB) or approved label for overview of ruxolitinib including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.

NCT04337359 Severe/Very Severe COVID-19 Illness Drug: Ruxolitinib


2 A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation

RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.

NCT04338958 Covid-19 Drug: Ruxolitinib

Primary Outcomes

Description: Patients achieving 25% reduction in hyperinflammation score (CIS) compared to baseline at day 7

Measure: overall response rate in reversal of hyperinflammation

Time: day 7 after start of therapy

3 Safety and Efficacy of Ruxolitinib for COVID-19

This study plans to learn more about the effects of a medicine called ruxolitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.

NCT04348071 COVID-19 Drug: Ruxolitinib

Primary Outcomes

Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.

Measure: Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs)

Time: Day 0 (screening) through Day 29

Description: An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.

Measure: Phase 2: Cumulative incidence of serious adverse events (SAEs)

Time: Day 0 (screening) through Day 29

Description: Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as standard of care (SOC). Mean changes from baseline to Day 15 will be reported.

Measure: Phase 2: Changes in white blood cell count (CBC) through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in hemoglobin through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in platelets through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in creatinine through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in glucose through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in prothrombin time (PT) through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in total bilirubin through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in ALT through Day 15

Time: Day 1 to Day 15

Measure: Phase 2: Changes in AST through Day 15

Time: Day 1 to Day 15

Description: Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.

Measure: Phase 2: Changes in white blood cell count (CBC) through End of Study (EOS)

Time: Day through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in hemoglobin through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in platelets through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in creatinine through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in glucose through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in prothrombin time (PT) though End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in total bilirubin through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in ALT through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 2: Changes in AST through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Description: The 8-point ordinal scale described below, where a lower score indicates a worse outcome, will be performed daily or as recommended by participant's physician as SOC. The percent of participants scored at each severity will be reported on Day 15. The 8-point ordinal scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Measure: Phase 3: Percentage of patients reporting each severity on an 8-point ordinal scale at Day 15

Time: Day 15

Secondary Outcomes

Measure: Phase 2: Change in the 8-point ordinal scale

Time: Day 1 to Day 29

Measure: Phase 2: Change in National Early Warning Score (NEWS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Change in the 8-point ordinal scale

Time: Day 1 to Day 29

Measure: Phase 3: Change in National Early Warning Score (NEWS)

Time: Day 1 to Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Time to an improvement of one category using the 8-point ordinal scale

Time: Day 1 to Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Time to an improvement of two categories using the 8-point ordinal scale

Time: Day 1 to Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Time to discharge or to a NEWS ≤2 and maintained for 24 hours, whichever occurs first

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Cumulative incidence of Grade 3 and 4 adverse events (AEs)

Time: Day 0 (screening) through Day 29

Measure: Phase 3: Cumulative incidence of serious adverse events (SAEs)

Time: Day 0 (screening) through Day 29

Measure: Phase 3: Duration of hospitalization

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Duration of new oxygen use

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Duration of new ventilator or ECMO use

Time: Day 1 to Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Incidence of discontinuation or temporary suspension of drug for any reason

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Incidence of new oxygen use

Time: Day 1 to Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Incidence of new ventilator use

Time: Day 1 to Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Number of oxygen free days

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Number of ventilator or ECMO free days

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: 14 day mortality rate

Time: Day 1 through Day 15

Measure: Phase 3: 28 day mortality rate

Time: Day 1 through Day 29

Measure: Phase 3: Changes in white blood cell count (CBC) through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in hemoglobin through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in platelets through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in creatinine through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in glucose through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in prothrombin time (PT) through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in total bilirubin through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in ALT through Day 15

Time: Day 1 to Day 15

Measure: Phase 3: Changes in AST through Day 15

Time: Day 1 to Day 15

Description: Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.

Measure: Phase 3: Changes in white blood cell count (CBC) through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in hemoglobin through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in platelets through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in creatinine through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in glucose through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in prothrombin time (PT) though End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in total bilirubin through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in ALT through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

Measure: Phase 3: Changes in AST through End of Study (EOS)

Time: Day 1 through Day 29 or hospital discharge, whichever is first

4 A Pilot Study of Ruxolitinib to Combat COVID-19

The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease manifestations.

NCT04354714 COVID-19 Drug: Ruxolitinib Procedure: Peripheral blood draw

Primary Outcomes

Measure: Overall survival

Time: Through 28 days

Secondary Outcomes

Measure: Length of hospital stay

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Length of ICU stay

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Duration of ventilator use

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Duration of vasopressors use

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Duration on renal replacement therapy

Time: Through completion of follow-up (estimated to be 7 months)

Description: -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing

Measure: Viral kinetics as measured by virologic failure

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Number of adverse events as measured by CTCAE v. 5.0

Time: Through completion of follow-up (estimated to be 7 months)

Measure: Proportion of participants with detectable virus

Time: Day 5

Measure: Proportion of participants with detectable virus

Time: Day 10

Measure: Proportion of participants with detectable virus

Time: Day 15

Measure: Proportion of participants with detectable virus

Time: Day 29

5 Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

This is 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 pneumonia.

NCT04362137 COVID-19 Drug: Ruxolitinib Drug: Placebo

Primary Outcomes

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.

Measure: Proportion of patients who die, develop respiratory failure [require mechanical ventilation] or require intensive care unit (ICU) care

Time: 29 days

Secondary Outcomes

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 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.

Measure: Clinical status

Time: Day 15, Day 29

Description: Percentage of patients with at least two points improvement in clinical status on the 9-point ordinal scale.

Measure: Percentage of patients with at least two-point improvement from baseline in clinical status

Time: Baseline, Day 15, Day 29

Description: Percentage of patients with at least one point improvement in clinical status on the 9-point ordinal scale.

Measure: Percentage of patients with at least one-point improvement from baseline in clinical status

Time: Baseline, Day 15, Day 29

Description: Percentage of patients with at least one point deterioration in clinical status on the 9-point ordinal scale.

Measure: Percentage of patients with at least one-point deterioration from baseline in clinical status

Time: Baseline, Day 15, Day 29

Description: Time to improvement from baseline category to one less severe category of the 9-point ordinal scale.

Measure: Time to improvement in clinical status

Time: 29 days

Description: Mean change from baseline in the 9-point ordinal scale.

Measure: Mean change from baseline in the clinical status

Time: Baseline, Day 15, Day 29

Description: Mortality rate at Day 15 and at Day 29

Measure: Mortality rate

Time: Day 15, Day 29

Description: Proportion of patients requiring mechanical ventilation

Measure: Proportion of patients requiring mechanical ventilation

Time: 29 days

Description: Duration of hospitalization

Measure: Duration of hospitalization

Time: 29 days

Description: The time to 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).

Measure: Time to discharge or to a NEWS2 score of ≤2

Time: 29 days

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).

Measure: Change from baseline in NEWS2 score

Time: Baseline, Days 3, 5, 8, 11, 15, and 29

Description: Change from baseline in peripheral oxygen saturation / fraction of inspired oxygen ratio (SpO2/FiO2 ratio)

Measure: Change from baseline in SpO2/FiO2 ratio.

Time: Baseline, Day 15, Day 29

Description: No oxygen therapy is required if oxygen saturation is ≥ 94% on room air.

Measure: Proportion of patients with no oxygen therapy

Time: Day 15, Day 29


No related HPO nodes (Using clinical trials)