None listed
Conditions
Interventions
Ruxolitinib 5 mg + standard of care
Type of group
One ruxolitinib 5 mg tablet will be administered orally twice per day approximately 12 hours apart in addition to the standar of care treatment for 14 days. Additional 14 days of study drug may be given in the opinion of the investigator. If a patient becomes intubated during the course of the study, study drug can be administered through a nasogastric tube.
Group name:Placebo + standard of care
Type of group
One ruxolitinib matching placebo tablet will be administered orally twice per day approximately 12 hours apart in addition to the standar of care treatment for 14 days. Additional 14 days of study drug may be given in the opinion of the investigator.. If a patient becomes intubated during the course of the study, placebo treatment can be administered through a nasogastric tube.
Sponsors
Novartis Pharma AG.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Male and female patients aged ≥ 12 years. 3. Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test. 4. Patient is currently (or will be) hospitalized. 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; • Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any drugs/metabolites as ruxolitinib. 2. Presence of severely impaired renal function. 3. Suspected uncontrolled, active bacterial, fungal, viral, or other infection. 4. Current or history of active TB infection. 5. History of progressive multifocal leukoencephalopathy. 6. Intubated between screening and randomization. 7. In ICU at time of randomization. 8. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs. 9. Intubated or in ICU for COVID-19 disease prior to screening. 10. Participating in any other investigational trials. 11. Unable to ingest tablets at randomization. 12. ALT ≥ 5 x ULN at screening. 13. Evidence of liver cirrhosis (Child A to C). 14. ANC < 1000/μL at screening. 15. Platelet count < 50,000/μL at screening. 16. Pregnant or nursing (lactating) women. 17. Females of childbearing potential unless the use of highly effective contraception method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of subjects developing clinical failure by Day 29 with ruxolitinib + SoC versus placebo + SoC therapy. The odds of clinical failure will be analyzed by a logistic regression model with treatment group, region, baseline clinical status based on the 9-point ordinal scale, age, and gender as covariates. Measure:Clinical failure, defined as the occurrence of death, respiratory failure (require mechanical ventilation), or ICU care by Day 29 Timepoints:Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of patients with no oxygen therapy (defined as oxygen saturation ≥ 94% on room air) will be analyzed separately using a logistic regression model with the same covariates as for the primary analyses, with baseline oxygen therapy status included. Measure:Oxygen saturation Timepoints:Day 15 and Day 29 ; Outcome name:Duration of hospitalization will be analyzed using a competing risk analysis framework. Measure:In-hospital outcomes Timepoints:Day 15 and Day 29 ; Outcome name:Time to discharge or to a National Early Warning Score (NEWS2) of ≤2 and maintained for 24 hours (whichever comes first) will be analyzed using a competing risk analysis framework. Measure:National Early Warning Score (NEWS2) Timepoints:Day 15 and Day 29 ; Outcome name:Se evaluaran los eventos adversos, signos vitales y evaluaciones de laboratorio Measure:Safety endpoints Timepoints:Day 29 ; Outcome name:The odds of observing a better category (lower number) of clinical status (9-category ordinal scale) at Day 15 will be analyzed with a proportional odds model (POM). The analysis will be repeated for the data at Day 29. Measure:9-category ordinal scale Timepoints:Day 15 and Day 29 | — |
Countries
Argentina, Brazil, Canada, Colombia, France, Germany, Italy, Mexico, Peru, Russian Federation, Spain, United Kindgdom, United States
Contacts
Public ContactCecilia Ynouye
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed