NCT04871646Unknown3 期
A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 586
- 试验地点
- 1
- 主要终点
- Time to recovery
研究概览
简要总结
A Double-blind, Multi-center, Multi-regional, Randomized controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19
详细描述
To evaluate the efficacy and safety of CKD-314 by comparing the study group and control group in hospitalized adult patients diagnosed with COVID-19 pneumonia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years
- •Patients diagnosed with COVID-19 infection and pneumonia
- •Patients who have voluntarily decided to participate in the study and signed the informed consent form If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained.
排除标准
- •Patients with history of hypersensitivity to the study drug
- •Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study
- •Patients who are deemed to ineligible to participate in the study for other reasons by the investigator
研究组 & 干预措施
CKD-314
Experimental
Treatment with CKD-314 + SOC
干预措施: CKD-314+SOC (Drug)
CKD-314 Placebo
Placebo Comparator
Treatment with CKD-314 Placebo + SOC
干预措施: CKD-314 Placebo+SOC (Drug)
结局指标
主要结局
Time to recovery
时间窗: From day1 to day 28
Day of recovery is defined as the first day on which the subject meets the criteria
次要结局
- Time to clinical improvement: Time to clinical improvement (TTCI)(From day1 to day 28)
研究者
研究点 (1)
Loading locations...
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