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)
- Conditions
- COVID-19 associated cytokine stormTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001662-11-FR
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 402
•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:
•Respiratory frequency = 30/min;
•Oxygen saturation = 93% on room air;
•Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).
Additional inclusion criteria as per main section in the protocol may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 332
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
•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.
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method