A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)
研究概览
简要总结
The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with 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
- Single (Participant)
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 4 days prior to clinical trial enrollment
- •Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening
- •Patients whose body temperature is measured according to the measured area without taking a fever reducer during screening:
- •[armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with rectum greater than 37.6 °C or eardrum greater than 37.5 °C] (Notes: Although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.)
- •Patients with evidence of lung invasions as a result of radiation tests
排除标准
- •Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation).
- •Patients who participated in other clinical trials related to COVID-
- •Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study.
- •Patients whose AST or ALT has increased by more than 5 times the normal lab value.
研究组 & 干预措施
Clevudine
Clevudine 120mg (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days)
干预措施: Clevudine (Drug)
Placebo
Matching Placebo (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days)
干预措施: Placebo (Drug)
结局指标
主要结局
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)
时间窗: within 15days
The primary efficacy endpoint for this clinical trial is the rate of patients with negative SARS-Coronavirus-2 (SARS-CoV-2) in a two-day continuous Real-Time-RT-PCR test from baseline to before the 15th day.
次要结局
- The rate of subjects indicated by the improvement of lung invasive(within Day 29 (or EOT))
- The change of viral load(Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline)
- The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests(Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline)