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)

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) - RUXCOVID

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001662-11-DE

Enrollment

402

Registered

2020-04-15

Start date

2020-05-05

Completion date

Unknown

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 associated cytokine storm

Interventions

Trade Name: Jakavi 5mg Tabletten Product Name: ruxolitinib Product Code: INC424 Pharmaceutical Form: Tablet INN or Proposed INN: ruxolitinib CAS Number: 1092939-17-7 Current Sponsor code: INC424 Other

Eligibility

Sex/Gender

All

Inclusion criteria

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 with lung imaging showing pulmonary infiltrates (chest X-ray or CT scan) prior to randomization. • Patients, who meet at least one of the below criteria: •pulmonary infiltrates (chest X ray or chest CT scan) •Respiratory frequency = 30/min; •Requiring supplemental oxygen; •Oxygen saturation = 94% on room air; •Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion 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. Additional exclusion criteria as per main section in the protocol may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 [ICU] care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29;Secondary Objective: evaluate efficacy (as measured by clinical status using a 9-point ordinal scale) of ruxolitinib + SoC therapy compared with placebo + SoC therapy, for treatment of COVID-19. evaluate efficacy of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, on in-hospital outcomes in patients with COVID-19. evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in change in the National Early Warning Score (NEWS2) score in patients with COVID-19. evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in change in SpO2/FiO2 ratio in patients with COVID-19. evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in proportion of patients with no oxygen therapy (defined as oxygen saturation = 94% on room air) in patients with COVID-19. evaluate safety of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, in treatment of patients with COVID-19. ;Primary end point(s): composite endpoint defined as proportion of patients who - die OR - develop respiratory failure (require mechanical ventilation) OR - require intensive care unit (ICU) care;Timepoint(s) of evaluation of this end point: 29 days	—

Measure

Time frame

Main Objective: 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 [ICU] care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29;Secondary Objective: evaluate efficacy (as measured by clinical status using a 9-point ordinal scale) of ruxolitinib + SoC therapy compared with placebo + SoC therapy, for treatment of COVID-19. evaluate efficacy of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, on in-hospital outcomes in patients with COVID-19. evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in change in the National Early Warning Score (NEWS2) score in patients with COVID-19. evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in change in SpO2/FiO2 ratio in patients with COVID-19. evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in proportion of patients with no oxygen therapy (defined as oxygen saturation = 94% on room air) in patients with COVID-19. evaluate safety of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, in treatment of patients with COVID-19. ;Primary end point(s): composite endpoint defined as proportion of patients who - die OR - develop respiratory failure (require mechanical ventilation) OR - require intensive care unit (ICU) care;Timepoint(s) of evaluation of this end point: 29 days

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Secondary

Measure	Time frame
Secondary end point(s): 1. 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 (noninvasive ventilation or highflow 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. 2. Percentage of patients with at least two-point improvement from baseline in clinical status on the 9-point ordinal scale. 3. Percentage of patients with at least one-point improvement from baseline in clinical status on the 9-point ordinal scale. 4. Percentage of patients with at least one-point deterioration from baseline in clinical status on the 9-point ordinal scale. 5. Time to improvement from baseline category to one less severe category of the 9-point ordinal scale. 6. Mean change from baseline in clinical status on the 9-point ordinal scale 7. Mortality rate 8. Proportion of patients requiring mechanical ventilation 9. Duration of hospitalization. 10. The time to discharge or to a NEWS2 score of =2 and maintained for 24 hours whichever comes first. 11. Change from baseline in NEWS2 score. 12. Change from baseline in SpO2/FiO2 ratio. 13. Proportion of patients with no oxygen therapy (no oxygen therapy is required if oxygen saturation = 94% on room air) ;Timepoint(s) of evaluation of this end point: 1. Day 15, Day 29 2. Baseline, Day 15, Day 29 3. Baseline, Day 15, Day 29 4. Baseline, Day 15, Day 29 5. 29 days 6. Baseline, Day 15, Day 29 7. Day 15,	—

Measure

Time frame

Secondary end point(s): 1. 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 (noninvasive ventilation or highflow 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. 2. Percentage of patients with at least two-point improvement from baseline in clinical status on the 9-point ordinal scale. 3. Percentage of patients with at least one-point improvement from baseline in clinical status on the 9-point ordinal scale. 4. Percentage of patients with at least one-point deterioration from baseline in clinical status on the 9-point ordinal scale. 5. Time to improvement from baseline category to one less severe category of the 9-point ordinal scale. 6. Mean change from baseline in clinical status on the 9-point ordinal scale 7. Mortality rate 8. Proportion of patients requiring mechanical ventilation 9. Duration of hospitalization. 10. The time to discharge or to a NEWS2 score of =2 and maintained for 24 hours whichever comes first. 11. Change from baseline in NEWS2 score. 12. Change from baseline in SpO2/FiO2 ratio. 13. Proportion of patients with no oxygen therapy (no oxygen therapy is required if oxygen saturation = 94% on room air) ;Timepoint(s) of evaluation of this end point: 1. Day 15, Day 29 2. Baseline, Day 15, Day 29 3. Baseline, Day 15, Day 29 4. Baseline, Day 15, Day 29 5. 29 days 6. Baseline, Day 15, Day 29 7. Day 15,

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Countries

France, Germany, Italy, Spain, United Kingdom, United States

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+49 911 273-12100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026