NCT04713176终止3 期
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days
研究概览
简要总结
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 19 as of the signed date in written consent
- •Subjects with COVID-19 according to RT-PCR test(within 10 days)
- •Subjects who need to be hospitalized and injected Remdesivir
排除标准
- •Subjects who cannot orally administer the investigational products
- •Subjects who requiring mechanical ventilation or ECMO
- •Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
- •Subjects who need administration of immunosuppressants
- •Subjects who are allergic or sensitive to investigational products or its ingredients
- •Crcl < 30 mL/min or eGFR < 30 mL/min/1.73m^2
- •AST or ALT >= 5xULN
- •Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
研究组 & 干预措施
DWJ1248 with Remdesivir
Experimental
Camostat mesylate 200 mg, Remdesivir
干预措施: DWJ1248 with Remdesivir (Drug)
Placebo with Remdesivir
Placebo Comparator
Placebo, Remdesivir
干预措施: Placebo with Remdesivir (Drug)
结局指标
主要结局
Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days
时间窗: Up to 29 days
Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7)
次要结局
- Desirable of Outcome Ranking (DOOR)(Day 15,29)
- Duration of Hospitalization(Day 29)
- Time to death(Day 15,29)
- Time to recovery(Day 3,5,8,11,15,22,29)
研究者
研究点 (1)
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