ITMCTR2100004363招募中4 期
A randomized, open-label, blank-controlled, multi-center clinical study for Lian-Hua Qing-Ke Tablets in the treatment of severe novel coronavirus pneumonia
Hebei Province Chest Hospital0 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. Patients with confirmed COVID-19 by Pathogen testing;
- •2. Above 18 years old (inclusive), both male and female;
- •3. Severe novel coronavirus pneumonia meets one of the following conditions;
- •(1) Shortness of breath, RR>=30 times/min;
- •(2) In the resting state, the oxygen saturation is less than or equal to 93% when inhaling air;
- •(3) Arterial partial pressure of oxygen (PAO 2)/oxygen concentration (FIO 2) <= 300mmHg (1mmHg=0.133kPa);
- •(4) Patients with progressive clinical symptoms, pulmonary imaging showed significant progression of >50% within 24 ~ 48 hours.
- •4. Voluntarily sign written informed consent.
排除标准
- •1. There is clear evidence of bacterial infection in respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
- •2. Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory tracts diseases that affecting clinical trial evaluation . Chest CT confirmed that patients with basic pulmonary diseases such as severe pulmonary interstitial lesions and bronchiectasis;
- •3. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc.;
- •4. Pregnant or lactating women;
- •5. Patients who participated in other clinical trials within the last 3 months;
- •6. An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients of the drug;
- •7. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy.
研究者
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