IRCT20200328046882N1招募中2 期
Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
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
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Written informed consent prior to performing study procedures
- •(SARS-CoV)-2 infection confirmed (PCR) test = 4 days before randomization
- •Currently hospitalized with fever
- •Peripheral capillary oxygen saturation (SpO2) = 94% on room air at screening
- •Radiographic evidence of pulmonary infiltrates
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19
- •Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
- •Evidence of multi-organ failure
- •Requiring mechanical ventilation at screening
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
- •Creatinine clearance <30mL/min
- •pregnant woman or man who his spouse is pregnant
- •Coadministration of amiodarone, HIV Protease Inhibitors, rifabutin or rifapentine , phenobarbital or oxcarbazepine
研究者
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