ITMCTR2100005197尚未招募1 期
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of Reduning injection in the treatment of viral pneumonia
The First Affiliated Hospital Of Guangzhou Medical University All Rights Reserved0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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 80（—）
- 性别
- All
入选标准
- •(1) Those who meet the diagnostic criteria of pneumonia in The Guidelines for diagnosis and Treatment of Adult Community-acquired Pneumonia (2016 edition) issued by respiratory Society of Chinese Medical Association;
- •(2) Community onset;
- •(3) New patchy infiltrating shadows, leaf or segmental consolidation shadows, ground glass shadows or interstitial changes, with or without pleural effusion on chest imaging;
- •(4) Procalcitonin (PCT) <0.1ng/ mL;
- •(5) Normal or low peripheral leukocytes (< 1 times ULN);
- •(6) Acute onset (duration =7 days), with one or more pneumonia-related clinical manifestations: fever (axillary temperature > 37.3?); Recent cough, expectoration or exacerbation of existing respiratory symptoms, with or without purulent sputum/chest pain/dyspnea/hemoptysis; Signs of lung consolidation and/or audible wet rales;
- •(7) PSI grade II-IV;
- •(8) Confirmed to be infected by viruses (including influenza virus, parainfluenza virus, rhinovirus, adenovirus, human metapneumonavirus and respiratory syncytial virus, positive for any of the pathogens);
- •(9) Age 18 ~ 80 years old, gender is not limited;
- •(10) Subjects voluntarily join the study and sign the informed consent.
排除标准
- •(1) Patients with definite diagnosis of acute attack of chronic bronchitis, bronchiectasis, tuberculosis, severe pulmonary interstitial lesions and other respiratory diseases; Patients with a definite diagnosis of bronchial asthma requiring hormone therapy;
- •(2) Within 48h before screening, the instructions have been clearly labeled as Chinese patent medicine or Chinese herbal prescription with functions of clearing heat, clearing blast, detoxifying, detoxifying and antiviral;
- •(3) Those who meet the diagnostic criteria of severe pneumonia in The Guidelines for diagnosis and Treatment of Adult Community Acquired Pneumonia in China (2016 edition), that is, those who meet one of the following major criteria or = three minor criteria:
- •A. Main criteria:
- •(1) The need for endotracheal intubation and mechanical ventilation;
- •? Septic shock still needs vasoactive drug therapy after active fluid resuscitation.
- •B. Minor criteria:
- •? Respiratory rate =30 times/min;
- •? Oxygenation index =250mmHg (1mmHg=0133kPa);
- •? Multiple pulmonary infiltration;
- •(4) Consciousness disorders and/or disorientation;
- •? Blood urea nitrogen =7.14mmol/L;
- •? Systolic pressure < 90 mmHg requires active fluid resuscitation.
- •(4) The subject was positive for novel coronavirus nucleic acid test;
- •(5) Complicated with heart, liver, kidney, digestive system, blood system and other serious diseases, such as malignant tumors (except for fully treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ); Acute hepatitis; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times upper limit of normal value (ULN), or total bile red > 2 times ULN; AST or ALT > 2 fold ULN and total bilirubin > 1.5 fold ULN; History of cirrhosis; Advanced clinical manifestations of liver disease, such as ascites or hepatic encephalopathy; Neutropenia (neutrophils < 0.5×10^9/L); Thrombocytopenia (platelet < 50×10^9/L); Hemophilia and other coagulation disorders; NYHA cardiac function grade = ?; Chronic kidney disease =3 stage;
- •(6) those who are known to be allergic to the composition of the drug in this study;
- •(7) Those who had participated in clinical trials of other drugs within 3 months before screening;
- •(8) Women who are breastfeeding or pregnant, or women of childbearing age who plan to become pregnant within 6 months after screening test, or those who have positive urine pregnancy test, or male patients who have fertility or sperm donation plan;
- •(9) persons with immunodeficiency or human immunodeficiency virus (HIV) antibody positive (e.g., organ or bone marrow transplants, AIDS patients, persons taking immunosuppressive drugs within 3 months prior to screening);
- •(10) Other conditions that the researcher considers unsuitable to participate in this study
研究者
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