ITMCTR2000003004招募中4 期
A multicenter, randomized, open, controlled trial for the efficacy and safety of Shen-Qi Fu-Zheng injection in the treatment of novel coronavirus pneumonia (COVID-19)
nion Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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 至 —（—）
- 性别
- All
入选标准
- •1) Aged >= 18 years;
- •2) In line with the diagnostic criteria of new coronavirus pneumonia diagnosis program, the patient was diagnosed as pneumonia infected by the new coronavirus;
- •3) Severe pneumonia index (PSI) class for III ~ IV;
- •4) The course of symptoms should be less than or equal to 8 days;
- •5) Volunteers and comply with the hospital regulations, can cooperate with the completion of the prescribed inspection;
- •6) Voluntary informed consent was signed prior to the trial.
排除标准
- •1)One of the following conditions:
- •Respiratory distress, RR >= 30 times/min;
- •At rest, oxygen saturation is less than 93%;
- •Artial arterial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg (1mmHg=0.133kPa);
- •Respiratory failure is present and mechanical ventilation is required;
- •Combined with other organ failure requires intensive care unit;
- •It is expected to be transferred to a non-study hospital within 72 hours.
- •2)Severe influenza and influenza patients with complications (such as secondary bacterial pneumonia, pneumonia caused by other pathogens and other viral pneumonia);Or the patient is hospitalized with severe influenza;
- •3)Patients with other upper respiratory tract infections: asthma requiring daily treatment, any other chronic respiratory diseases, respiratory bacterial infections such as suppurative tonsillitis, acute tracheal bronchitis, sinusitis, otitis media and other respiratory diseases affecting clinical trial evaluation.Imaging confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis and other basic pulmonary diseases;
- •4)Past or present diseases may affect the outcome of the study, such as unresectable malignant tumors, hematological diseases, active bleeding, malignant fluid, liver and kidney diseases, nervous system diseases, endocrine system diseases, etc.;
- •5)Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ transplantation, etc.;
- •6)A woman who is pregnant or breastfeeding;
- •7)Test drug components allergy, or allergic constitution;
- •8)Patients with a history of substance abuse;
- •9)Participants in other clinical trials in the last 3 months;
- •10)The investigator considers it inappropriate to participate in this clinical trial.
研究者
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