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|drug3903||iv Tocillizumab (TCZ) Wiki||0.32|
|drug3933||metformin glycinate Wiki||0.32|
|drug3968||none - observational Wiki||0.32|
|drug2449||Peripheral blood draw Wiki||0.22|
|drug3389||Therapeutic Plasma Exchange Wiki||0.22|
|drug2732||Questionnaire Administration Wiki||0.09|
|drug3199||Standard of care Wiki||0.06|
|drug2557||Placebo oral tablet Wiki||0.06|
|D024821||Metabolic Syndrome NIH||0.32|
|D003924||Diabetes Mellitus, Type 2 NIH||0.09|
|D018352||Coronavirus Infections NIH||0.08|
There are 10 clinical trials
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.
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.
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.
Description: Patients achieving 25% reduction in hyperinflammation score (CIS) compared to baseline at day 7Measure: overall response rate in reversal of hyperinflammation Time: day 7 after start of therapy
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.
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
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
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 activitiesMeasure: Phase 3: Percentage of patients reporting each severity on an 8-point ordinal scale at Day 15 Time: 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
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.
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 testingMeasure: Viral kinetics as measured by virologic failure Time: Through completion of follow-up (estimated to be 7 months)
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.
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.
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
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 29Measure: Mortality rate Time: Day 15, Day 29
Description: Proportion of patients requiring mechanical ventilationMeasure: Proportion of patients requiring mechanical ventilation Time: 29 days
Description: Duration of hospitalizationMeasure: 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
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.
Description: Defined as greater than or equal to 33% decrease in cytokine load in one-third or more participantsMeasure: Overall Response Rate Time: 14 days
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.
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 29
Description: Number of days participant did not require mechanical ventilationMeasure: Number of Ventilator free days Time: Day 29
Description: Number of days participant is out of the ICUMeasure: Number of ICU free days Time: Day 29
Description: Number of days participant did not receive supplemental oxygenMeasure: Oxygen free days Time: Day 29
Description: Number of days without use of vasopressor therapyMeasure: Vasopressor free days Time: Day 29
Description: Number of days Partcipant is out of the hospitalMeasure: Hospital free days Time: Day 29
Description: 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 deadMeasure: Improvement in the COVID-19 ordinal scale Time: Day 15 and 29
Description: 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 29
Description: 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
The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.
Description: Scale range from 0 (uninfected) to 9 (dead)Measure: Absolute change in pneumonia severity on the modified WHO COVID-19 Ordinal Scale Time: Day 14, 28
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports