CTRI/2020/09/027680暂停3 期
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)
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ââ?°Â¥ 12 years (or ââ?°Â¥ 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 ââ?°Â¥ 30/min; Requiring supplemental oxygen; Oxygen saturation ââ?°Â¤ 94% on room air;
排除标准
- •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 Ã?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.
研究者
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