Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/027680
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
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;
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 < 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) womenOther protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method