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 PHARMA AG0 个研究点目标入组 402 人开始时间: 2020年7月3日最近更新: 2021年1月18日

适应症

试验速览

暂无简介。

•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 Xray or CT scan) prior to randomization.
•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 (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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.
•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) women.
•Additional exclusion criteria as per main section in the protocol may apply.

发起方