NCT04623021已完成2 期
An Open-label, Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 11
- 主要终点
- Time to clinical improvement
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of CKD-314 (Nafabelltan) compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale 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
- None
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
- •Men and women Aged ≥18 years
- •Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:
- •Subjects who are eligible for diagnosis/evaluation to chest X-ray or chest CT
- •Women of childbearing potential (including women in post menopause for less than 2 years) must use a medically acceptable forms of birth control and agree to continue its use during the study
- •Subjects (or legally authorized representative) should be able to understand and agree to comply with the clinical trial and to provide a written consent document prior to initiation of any study procedure
排除标准
- •Subjects who have a record of HIV or AIDS
- •Subject has a serious chronic disease
- •Active bleeding or ongoing clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment
- •Pregnant or lactating females
- •Subjects with liver cirrhosis whose Child-Pugh score is B or C
- •Subjects who have liver disease abnormalities with ALT or AST > 5 times ULN
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration)
- •QTcB or QTcF >500ms
- •Subjects who have clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation) in medical history
- •Subjects with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator's opinion
- •Subjects who are not appropriate for the study, as the investigator's opinion
- •Subjects who have hypersensitivity to the investigational drug
- •Subjects participated in any other clinical trial (including drugs for the treatment of COVID-19) 3 months prior to screening
研究组 & 干预措施
Nafamostat + Standard of Care
Experimental
Nafamostat mesylate on top of standard of care
干预措施: Nafamostat Mesilate (Drug)
结局指标
主要结局
Time to clinical improvement
时间窗: up to 28 days
Time to clinical improvement (TTCI) was defined as time (days) from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first
次要结局
- Incidence of non-invasive ventilation or high flow oxygen use(up to 28 days)
- Incidence of supplement oxygen use(up to 28 days)
- Time to recovery(up to 28 days)
- Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status(Day 4, 7, 11, 14 and 28)
- Time to normalize the CRP(up to 28 days)
- Duration of hospitalization(up to 28 days)
- Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use(up to 28 days)
- Duration of supplement oxygen use(up to 28 days)
- Changes on CT scan/X-ray(Day 5, 11, 14 and 28)
- Change from baseline of CRP(Day 4, 7, 11, 14 and 28)
- Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use(up to 28 days)
- 28-Day mortality(up to 28 days)
- Proportion of patients with recovery as defined as the subject satisfies one of the following(Day 4, 7, 11, 14 and 28)
- Change of clinical status assessed by 7-category ordinal scale(Day 4, 7, 11, 14 and 28)
- Change in National Early Warning Score (NEWS)(Day 4, 7, 11, 14 and 28)
- Duration of non-invasive ventilation or high flow oxygen use(up to 28 days)
- Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours(up to 28 days)
研究者
研究点 (11)
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