Clinical study of nebulized Xiyanping injection in the treatment of novel coronavirus pneumonia (COVID-19)
- Conditions
- novel coronavirus pneumonia (COVID-19)
- Registration Number
- ITMCTR2000003000
- Lead Sponsor
- Renmin Hospital of Wuhan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. 18 years old <= age <= 60 years old at the time of screening;
2. Pharyngeal swabs, alveolar lavage fluid, or sputum specimens during screening showed that 2019-nCoV virus nucleic acid test results were positive for at least two of nCov-EP, nCov-NP, and nCovORF1ab, in line with the release of a new coronavirus infection by the National Health and Medical Commission Diagnostic criteria for confirmed cases in the pneumonia diagnosis and treatment plan (trial version 5);
3. The investigator determined that aerosolized inhalation treatment was appropriate, and volunteered to participate in the study and signed informed consent.
1. Chronic lung diseases requiring long-term oxygen therapy;
2. Long-term application of glucocorticoids due to underlying diseases;
3. Based on the researcher's judgment, previous or current diseases 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.;
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 diseases affecting clinical trial evaluation, Chest CT confirmed that patients with severe pulmonary interstitial lesions, bronchiectasis and other underlying lung diseases;
4. Breastfeeding or pregnancy test result is positive during screening or test;
5. Allergic constitution (persons who are allergic to more than 2 types of substances), persons who are allergic to similar drugs in the past or those who are known to be allergic to the ingredients and auxiliary materials in the test drugs;
6. The investigator decides that it is not in the best interest of the subject to participate in the study, or that the subject has any situation in which the protocol cannot be fully followed.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Imaging changes;Etiology and laboratory testing;PaO2/SPO2;Liquid balance;vital signs (Body temperature, blood pressure, heart rate, breathing rate);Ventilator condition;Respiratory symptoms and signs (Lung sounds, cough, sputum);
- Secondary Outcome Measures
Name Time Method Hemodiafiltration;Oxygen time (hours);Mechanical ventilation time;ICU days;Application of pulmonary surfactant;