Traditional Chinese Medicine for Severe COVID-19
A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.
Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.
This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Beijing
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Beijing、Beijing、中国、100091
- Hao Li
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-
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
Key Inclusion Criteria:
- Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
- Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.
Key Exclusion Criteria:
- Age >85 years
- After cardiopulmonary resuscitation
- Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
- Respiratory failure and need mechanical ventilation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Traditional Chinese Medicine
TCM prescription and conventional treatments
|
Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.
|
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无干预：Control
conventional treatments
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Length of hospital stay (days)
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration (days) of supplemental oxygenation
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
|
CT imaging changes
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
|
Mortality rate
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
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Time to Clinical Improvement (TTCI)
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
|
The pneumonia severity index scores
大体时间：First treatment date up to 3 months
|
The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia.
It ranges from 0-395 scores and a higher score indicates higher death risk.
|
First treatment date up to 3 months
|
|
Time to COVID-19 nucleic acid testing negativity in throat swab
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
|
Blood immune cell count
大体时间：Baseline, 7 and/ or 14 days
|
Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
|
Baseline, 7 and/ or 14 days
|
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Serum inflammatory markers
大体时间：Baseline, 7 and/ or 14 days
|
Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
|
Baseline, 7 and/ or 14 days
|
|
Erythrocyte sedimentation rate
大体时间：Baseline, 7 and/ or 14 days
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Changes in erythrocyte sedimentation rate from baseline.
|
Baseline, 7 and/ or 14 days
|
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Platelet and D-dimer changes
大体时间：Baseline, 7 and/ or 14 days
|
Changes in platelets and D-dimers from baseline.
|
Baseline, 7 and/ or 14 days
|
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Creatinine changes
大体时间：Baseline, 7 and/ or 14 days
|
Changes in serum creatinine from baseline.
|
Baseline, 7 and/ or 14 days
|
|
Muscle enzymes changes
大体时间：Baseline, 7 and/ or 14 days
|
Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
|
Baseline, 7 and/ or 14 days
|
|
Usage of antibiotics
大体时间：First treatment date up to 3 months
|
Dosing time and amounts of antibiotics；the categories of the antibiotics
|
First treatment date up to 3 months
|
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Usage of glucocorticoids
大体时间：First treatment date up to 3 months
|
Dosing time and amounts of glucocorticoids
|
First treatment date up to 3 months
|
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Frequency of adverse events
大体时间：First treatment date up to 3 months
|
First treatment date up to 3 months
|
合作者和调查者
调查人员
- 学习椅：Hao Li, Professor、Xiyuan Hospital of China Academy of Chinese Medical Sciences
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
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