Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Drug: Ruxolitinib: Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Intervention2: Drug: Placebo: Matching-image placebo
Control
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1-Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed. 2-Male and female patients aged � 12 years (or � the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals). 3-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. 4-Patients currently hospitalized or will be hospitalized prior to randomization. 5-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;
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 �¼mol/L), or have estimated creatinine clearance 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) womenOther protocol-defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who die, develop respiratory failure [require mechanical ventilation] or require intensive care unit (ICU) care 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.Timepoint: Time Frame: 29 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to improvement in clinical statusTimepoint: [ Time Frame: 29 days ];Change from baseline in NEWS2 scoreTimepoint: [ Time Frame: Baseline, Days 3, 5, 8, 11, 15, and 29 ];Change from baseline in SpO2/FiO2 ratio.Timepoint: [ Time Frame: Baseline, Day 15, Day 29 ];Clinical statusTimepoint: Time Frame: Day 15, Day 29;Duration of hospitalizationTimepoint: [ Time Frame: 29 days ];Mean change from baseline in the clinical statusTimepoint: [ Time Frame: Baseline, Day 15, Day 29 ];Mortality rateTimepoint: [ Time Frame: Day 15, Day 29 ];Percentage of patients with at least one-point deterioration from baseline in clinical statusTimepoint: [ Time Frame: Baseline, Day 15, Day 29 ];Percentage of patients with at least one-point improvement from baseline in clinical statusTimepoint: [ Time Frame: Baseline, Day 15, Day 29 ];Percentage of patients with at least two-point improvement from baseline in clinical statusTimepoint: [ Time Frame: Baseline, Day 15, Day 29 ];Proportion of patients requiring mechanical ventilationTimepoint: [ Time Frame: 29 days ];Proportion of patients with no oxygen therapyTimepoint: [ Time Frame: Day 15, Day 29 ];Time to discharge or to a NEWS2 score of ââ?°Â¤2Timepoint: [ Time Frame: 29 days ] | — |
Countries
Argentina, Brazil, Canada, Colombia, France, Germany, India, Italy, Mexico, Panama, Peru, Russian Federation, South Africa, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed