NCT04891302已完成2 期
A Double Blind, Randomized, Placebo-controlled, Multi-center, Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Mild and Moderate COVID-19
Bukwang Pharmaceutical11 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年3月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 11
- 主要终点
- The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
研究概览
简要总结
The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 150 mg versus placebo once daily administration with standard of care therapy for 10 days in patients with mild and moderate COVID-19.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years of age
- •COVID-19 confirmed by a real-time RT-PCR tests, and hospitalized
- •Patients who experienced first symptom related to COVID-19 within 7days prior to enrollment and confirmed 2 or more relative symptoms at the time of randomization.
- •Patients with peripheral capillary oxygen saturation(SpO2) greater than 94% at the time of screening, who do not need supplemental oxygen therapy.
排除标准
- •Patients who participated in other clinical trials related to COVID-19
- •Patients who were administered drugs directly to COVID-19 24hours prior to the start of the study.
- •Patients who need oxygen supply or breathing device (non-invasive mechanical ventilation(via mask)), mechanical ventilator requirement (via endotracheal tube or tracheostomy tube, ECMO requirement) at the time of screening or baseline
- •Patients whose AST or ALT has increased by more than 5 times the normal lab value.
研究组 & 干预措施
Clevudine
Experimental
Clevudine 150 mg once a day for 10 days
干预措施: Clevudine (Drug)
Placebo
Placebo Comparator
Matching Placebo once a day for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
时间窗: Day 11
次要结局
- The amount of SARS-CoV-2 virus reduction on Day 4, Day 8, Day 15, Day 22 and Day 29 compared to the the baseline.(Day 4, Day 8, Day 15, Day 22 and Day29 (or EOT))
- The viral load change from baseline.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day29)
- The time consumed for clinical improvement.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT))
- The rate of subjects tested as negative SARS-CoV-2 in consecutive two days of Real-Time RT-PCR tests.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT))
- The cycle threshold values change from baseline.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day29)
- The procalcitonine change from baseline.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day29)
- The rate of subjects who received new oxygen supplement at visit after baseline.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT))
- The rate of subjects indicated by the improvement of lung invasive.(Within Day 29 (or EOT))
- The C-reactive protein change from baseline.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day29)
- The time of subjects discharged from the hospital.(Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT))
研究者
研究点 (11)
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