jRCT2021200018已完成不适用
An exploratory Phase II investigator-initiated clinical trial of the efficacy and safety of TM5614 in patients with SARS-CoV-2 pneumonia(COVID-19)
未提供0 个研究点目标入组 30 人开始时间: 2020年10月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Inpatients over the age of 20 obtained by written consent
- •(2) Patients who are positive for COVID-19 by RT-PCR test or antigen test
- •(3) Patients with a finding consistent with novel coronavirus pneumonia on chest CT examination
- •(4) Patients with room air SpO2 <95% at rest
- •(5) Patients who require less than 5 L/min oxygen concentration
- •(6) Patients who are not on a ventilator
- •(7) Patients whose AST or ALT value is 2.5 times or less than the institutional upper limit
- •(8) Patients whose total bilirubin level is 2.5 times or less than the institutional upper limit
- •(9) Patients with creatinine clearance (calculated by Cockcroft-Gault formula) of 30 mL/min or more
排除标准
- •(1) Patients on home oxygen therapy
- •(2) Kidney disease patients undergoing dialysis treatment
- •(3) Patients with a history or complications of malignant tumors (except for those with no recurrence or new onset for at least 5 years after treatment)
- •(4) Patients with cirrhosis (Child-Pugh score class B and C)
- •(5) Pregnant or lactating patients
- •(6) Patients who have participated in or are currently participating in other clinical trials within 30 days prior to enrollment in this clinical trial
- •(7) Patients with bleeding tendency
- •(8) Patients on anticoagulants and other concomitantly prohibited drugs that are difficult to discontinue
- •(9) Patients judged by the investigator or co-investigator to be inappropriate for other reasons
结局指标
主要结局
-
Existence of deterioration of oxygenation requiring ventilator management
次要结局
- Survival for 28 days(28 days from the start of study drug administration)
- Duration of hospitalization(after starting study drug administration)
- Number of days required for oxygen administration(after starting study drug administration)
- P/F ratio (PaO2/FiO2)
- Changes in the proportion of lung field lesions(before and after study drug administration)
研究者
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