NCT04628143已完成2 期
Open-label, Multi-center, Randomized Controlled, Phase 2 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
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 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
详细描述
Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with 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
- 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:
- •COVID-19 infection: SARS-CoV-2 positive confirmed by RT-PCR
- •Pneumonia: A reliable diagnosis of new lung infiltration on a chest CT scan or chest radiograph
- •Subjects within 72 hours after confirmed COVID-19 pneumonia
- •Subjects with a seven-category ordinal scale of clinical status of 4 (hospitalization, requiring supplemental oxygen) or 5 (hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation)
- •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
- •Subject has a serious chronic disease
- •Subject requiring invasive mechanical ventilation at the time of screening
- •Subject with rapidly(within 3 days) deteriorating clinical condition according to the investigator's opinion
- •Subject who have a record of HIV or AIDS
- •Subject taking corticosteroids[However, ① steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ② topical steroids,
- •③ Patients who are administering inhaled steroids are not eligible for exclusion]
- •Subject taking immunosuppressants/immunomodulators
- •Subject with liver cirrhosis whose Child-Pugh score is B or C
- •Subject with hyperkalemia (K> 5.1mmol/L)
- •Subject who have liver disease abnormalities with ALT or AST > 5 times ULN
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min
- •QTc >500ms
- •Subject who have hypersensitivity to the investigational drug
- •Pregnant or lactating females
- •Subject who are not appropriate for the study, as the investigator's opinion
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
- 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, 10, 14, 21 and 28)
研究者
研究点 (1)
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