Baricitinib 对中度和重度 COVID-19 患者的疗效和安全性
Baricitinib 在中度和重度 COVID-19 患者中的疗效和安全性——在孟加拉国进行的一项多中心随机双盲安慰剂对照临床试验
This is multicenter clinical trial to evaluate efficacy and safety of Baricitinib in treatment for COVID-19. This trial will compare Baricitinib, a drug recommended for Rheumatoid Arthritis, against standard of care, to assess its relative effectiveness against COVID-19. By enrolling patients in multiple centers, this trial aims to recruit more patients to evaluate whether this drug slow disease progression or improve survival. Currently no effective therapeutics treatment or vaccine is available in the world for this highly transmissible respiratory borne infection, Covid-19. A number of drug trials are ongoing to measure the efficacy of the drug against the virus. Bangladesh as a resource limited country with limitation to provided health care services to the huge number of Covid-19 patients who will need hospitalization will be benefited from this study. There is no physical, psychological, social, legal risk in this study. The trial therapeutic will be approved form the Directorate of drug Administration (DGDA), Bangladesh.
研究概览
研究类型
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
Dhaka、孟加拉国
- Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- SARS-Co-V2 positivity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
- Age >18 years
- Presence of any symptoms suggestive of COVID-19, such as such as fever, fatigue, cough (with or without sputum production), shortness of breath, sore throat, nasal congestion, anorexia, malaise, or headache. Rarely, patients may also present with diarrhea, nausea, and vomiting
- Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography
- Moderate and severe COVID-19 as per previous definition national guideline/WHO
- Give informed written consent
Exclusion Criteria:
- Absolute lymphocyte count <500/mm3 and absolute neutrophil count of <1000/mm3 and Hemoglobin 8gm/dl or less
- Severe hepatic or renal impairment
- Live vaccine within 3 months prior to first dose of the drug
- Pregnancy
- Lactation
- Current malignancy or history of malignancies over the previous 5 years and/or history of malignancies in first degree relatives
- Transaminases values 5-fold higher than the upper normal limit
- Proven evidence of concomitant bacterial infections
- Clinical evidences suggestive of pulmonary tuberculosis, or past history and/or history of contact with TB patient
- Known hypersensitivity to Baricitinib
- Those who have received Tocilizumab previously
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Baricitinib
Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14 |
Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
其他名称：
|
|
安慰剂比较：Placebo
Continued SOC according as mentioned in operational definition in the protocol |
Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical status assessed by a 7-point ordinal scale on Day 14
大体时间：Day 1 to Day 14
|
The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst(ie, lowest ordinal) score from the previous day will be recorded, ie, on Day 3, the lowest ordinal score from Day 2 is obtained and recorded for Day 2. The scale is as follows:
|
Day 1 to Day 14
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
发生治疗紧急不良事件的参与者比例
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
临床改善时间（天）：临床改善定义为从第 1 天起临床状态改善 ≥ 2 分（7 分顺序量表）
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
|
从基线临床状态改善 ≥ 1 点的时间（天）
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
|
恢复时间：定义为临床状态从基线评分 2 到 5 改善到评分 6 或 7，或从基线评分 6 改善到评分 7
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
|
氧疗持续时间（天）
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
|
氧气支持状态从基线发生变化的患者比例
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
|
住院时间（天）
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
|
第 28 天全因死亡率的患者人数
大体时间：第 1 天到第 28 天
|
第 1 天到第 28 天
|
合作者和调查者
调查人员
- 首席研究员：Md. Titu Miah, MBBS, FCPS、Dhaka Medical College
- 首席研究员：Md. Mujibur Rahman, MBBS, MD、Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.