Tetrandrine Tablets Used in Hospitalized Adults With COVID-19: a Double-blind, Placebo-controlled, Randomised Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Diagnosed with critical COVID-19 pneumonia
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical.
详细描述
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. The secondary objective is to evaluate the clinical indicators of COVID-19 with tetrandrine tablets treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent form voluntarily for the trial.
- •Male or female aged between 18 and 85 years (inclusive).
- •Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test.
- •Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa).
- •No birth plan and must agree to take effective contraceptive methods.
排除标准
- •Received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study.
- •Patient must be on invasive mechanical ventilation/ECMO at baseline.
- •Any clinically important serious diseases unstable or uncontrolled.
- •Allergy history to any biological or other agent.
- •Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-
- •Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study.
- •Investigator think the subject should not participate in the study.
研究组 & 干预措施
tetrandrine group
Tetrandrine 60mg TID for 28 days
干预措施: Tetrandrine (Drug)
placebo group
placebo TID for 28 days
干预措施: Tetrandrine (Drug)
结局指标
主要结局
Diagnosed with critical COVID-19 pneumonia
时间窗: 84 days
Diagnosed with COVID-19 pneumonia according to the criteria and meeting one of the following conditions: a. respiratory failure requiring mechanical ventilation, b. shock, c. other organ dysfunction requiring ICU management.
次要结局
未报告次要终点
研究者
Sun Yongchang
Professor
Peking University Third Hospital