KCT0005003尚未招募未知
Treatment effect of Nafamostat mesilate in patients with COVID-19 pneumonia: open labelled randomized controlled clinical trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •1. 18 years old or older
- •2. Patients who have been confirmed of COVID-19 infection and has evidence for pneumonia
- •A. Confirmation of COVID-19 infection by RT-PCR of SARS-CoV-2
- •B. Definite diagnosis of new infiltration of the lungs by chest CT scan of chest radiographic inspection
- •3. Patients who are within 72 hours of COVID-19 pneumonia confirmation
- •4. Patients with 3 (hospitalization, not requiring supplemental oxygen) or higher in seven-category ordinal scale of clinical status
- •5. Patients who are eligible for diagnosis/evaluation to chest CT scan and related to it
- •6. Patients should be able to understand the essence of the clinical trial and to submit a written consent document. For the patients who can understand the nature of the research but cannot sign the document, a relative can agree to the study.
排除标准
- •1. Patients who have a record of HIV or AIDS
- •2. Female patients, either who are pregnant within 6 months before the investigation, who breast-fed babies within 3 months before the investigation, or who may get pregnant or breast-feed within 1 month after the investigation is over
- •3. Patients at high risk of death within 3 days of randomized assignment, by the judge of the investigator
- •4. Patients with liver cirrhosis whose Child-Puch score is B or C
- •5. Patients who have liver disease abnormalities with ALT or AST > 5 times ULN
- •6. Patients who can be in danger or who shows clinically-important other conditions which may interfere with the evaluation or completion of the test procedure, as the investigator’s opinion
- •7. Patients who are not appropriate for the test, as the investigator’s opinion
- •8. Patients who have hypersensitivity to the investigational drug
研究者
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