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 |
There are 5 clinical trials
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 7
Measure: overall response rate in reversal of hyperinflammation Time: day 7 after start of therapyThis 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 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 15Description: 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 firstDescription: 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 15Description: 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 firstThe 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 testing
Measure: Viral kinetics as measured by virologic failure Time: Through completion of follow-up (estimated to be 7 months)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 daysDescription: 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 29