Covid 19 Research using Clinical Trials (Home Page)
RuxolitinibWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2497 | Therapeutic Plasma Exchange Wiki | 0.33 |
| drug797 | Duplex ultrasound and Computed Tomography Angiography Wiki | 0.33 |
| drug297 | BM-MSCs Wiki | 0.33 |
| drug1203 | Infusion placebo Wiki | 0.33 |
| drug657 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.33 |
| drug1345 | Linagliptin Wiki | 0.33 |
| drug1218 | Insulin regimen Wiki | 0.33 |
| drug1795 | Peripheral blood draw Wiki | 0.24 |
| drug1853 | Placebo oral tablet Wiki | 0.06 |
| drug1822 | Placebo Wiki | 0.04 |
| drug1086 | Hydroxychloroquine Wiki | 0.03 |
Correlated MeSH Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D016769 | Embolism and Thrombosis NIH | 0.19 |
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.14 |
| D054556 | Venous Thromboembolism NIH | 0.13 |
| D020246 | Venous Thrombosis NIH | 0.11 |
| D011655 | Pulmonary Embolism NIH | 0.11 |
| D004617 | Embolism NIH | 0.10 |
| D013923 | Thromboembolism NIH | 0.09 |
| D018352 | Coronavirus Infections NIH | 0.08 |
| D013927 | Thrombosis NIH | 0.08 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.07 |
| D004630 | Emergencies NIH | 0.06 |
| D016638 | Critical Illness NIH | 0.05 |
| D011024 | Pneumonia, Viral NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.04 |
| D013577 | Syndrome NIH | 0.04 |
Correlated HPO Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005978 | Type II diabetes mellitus HPO | 0.14 |
| HP:0002625 | Deep venous thrombosis HPO | 0.11 |
| HP:0002204 | Pulmonary embolism HPO | 0.11 |
| HP:0001907 | Thromboembolism HPO | 0.08 |
| HP:0002090 | Pneumonia HPO | 0.04 |
There are 9 clinical trials
Clinical Trials
1 A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug. This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.
NCT04331665 COVID-19 Pneumonia Drug: Ruxolitinib MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Measure: Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more) Time: 6 months
Measure: Number of adverse events Time: 9 months
Secondary Outcomes
Measure: All cause mortality rate Time: 9 months
Measure: Average duration of hospital stay Time: 9 months
2 Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
Primary Outcomes
Measure: Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more) Time: 6 monthsMeasure: Number of adverse events Time: 9 months
Secondary Outcomes
Measure: All cause mortality rate Time: 9 monthsMeasure: Average duration of hospital stay Time: 9 months
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
3 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 therapy4 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 29Description: 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 29Description: 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 15Measure: 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 firstMeasure: 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 15Secondary Outcomes
Measure: Phase 2: Change in the 8-point ordinal scale Time: Day 1 to Day 29Measure: 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 firstMeasure: 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
5 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 daysSecondary 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
6 An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.
NCT04355793 COVID-19 Drug: Ruxolitinib MeSH:Emergencies
7 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 Cytokine Storm (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 daysSecondary 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 29Description: 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 29Description: 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 29Description: 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 29Description: 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 daysDescription: Mean change from baseline in the 9-point ordinal scale.
Measure: Mean change from baseline in the clinical status Time: Baseline, Day 15, Day 29Description: Mortality rate at Day 15 and at Day 29
Measure: Mortality rate Time: Day 15, Day 29Description: Proportion of patients requiring mechanical ventilation
Measure: Proportion of patients requiring mechanical ventilation Time: 29 daysDescription: Duration of hospitalization
Measure: Duration of hospitalization Time: 29 daysDescription: 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 daysDescription: 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 29Description: 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 29Description: 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 298 Interventional Study to Evaluate the Efficacy of Therapeutic Plasma Exchange (TPE) Alone or in Combination With Ruxolitinib in COVID-19 Positive Patients With PENN Grade 2, 3, 4 Cytokine Released Syndrome (CRS)
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome. It is hypothesized that dual intervention of acute apheretic depletion of cytokines and concomitant suppression of production will produce superior amelioration of the cytokine load and to help to prevent cytokine load rebound. This protocol is envisioned as a pilot study (n=20) for hypothesis generation for future investigation.
NCT04374149 Cytokine Release Syndrome COVID19 Procedure: Therapeutic Plasma Exchange Drug: Ruxolitinib MeSH:Syndrome
Primary Outcomes
Description: Defined as greater than or equal to 33% decrease in cytokine load in one-third or more participants
Measure: Overall Response Rate Time: 14 days9 A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
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.
NCT04377620 COVID-19 Drug: Placebo Drug: Ruxolitinib
Primary Outcomes
Description: 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.
Measure: Proportion of participants who have died due to any cause Time: Up to Day 29Secondary Outcomes
Description: Number of days participant did not require mechanical ventilation
Measure: Number of Ventilator free days Time: Day 29Description: Number of days participant is out of the ICU
Measure: Number of ICU free days Time: Day 29Description: Number of days participant did not receive supplemental oxygen
Measure: Oxygen free days Time: Day 29Description: Number of days without use of vasopressor therapy
Measure: Vasopressor free days Time: Day 29Description: Number of days Partcipant is out of the hospital
Measure: Hospital free days Time: Day 29Description: Clinical status of participant 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
Measure: Improvement in the COVID-19 ordinal scale Time: Day 15 and 29Description: 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.
Measure: Change in SOFA Score Time: from baseline to Days 3, 5, 8, 11, 15, and 29Description: Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measure: Number of treatment-related adverse events Time: Day 29