A randomized, open, parallel-controlled clinical trial on the efficacy and safety of Jingyebaidu granules in treating novel coronavirus pneumonia (COVID-19)
- Conditions
- novel coronavirus pneumonia (COVID-19)
- Registration Number
- ITMCTR2000002999
- Lead Sponsor
- Tongji Hospital, Tongji Medical College of HUST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who were confirmed diagnosis of 2019-ncov virus pneumonia, according to the pneumonia diagnosis and treatment program for novel coronavirus infection (trial version 5),including clinical symptoms, pulmonary CT manifestations and positive nucleic acid test;
2. Inpatients 18 years old (including 18), regardless of gender;
3. Willing to participate in this clinical trial and sign the informed consent.
1. Patients with severe pneumonia requiring mechanical ventilation and severe new coronavirus infection with pneumonia;
2. Death is expected within 48 hours;
3. There is clear evidence of bacterial infection in respiratory tract infections caused by primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformation, congenital heart disease, gastroesophageal reflux disease, pulmonary dysplasia and other basic diseases;
4 subjects with the following conditions: daily treatment of asthma, any other chronic respiratory diseases, respiratory bacterial infections such as suppurative tonsillitis, acute tracheal bronchitis, sinusitis, otitis media and other respiratory diseases that affect clinical trial evaluation.Chest CT confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis and other basic pulmonary diseases;
5. According to the researcher's judgment, the previous or current diseases may affect the patient's participation in the trial or the outcome of the study, including malignant diseases, autoimmune diseases, severe malnutrition, liver and kidney diseases, blood diseases, nervous system diseases, and endocrine diseases;He is suffering from serious diseases that affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc.
Unable to cooperate in mental state, suffering from mental disease, unable to control, unable to express clearly;
Allergic constitution (such as allergic to two or more drugs or food) or history of allergy to this product and conventional treatment drugs;
8. A history of substance abuse or dependence;
9. Pregnant or nursing women;
10. Other researchers consider it inappropriate to participate in clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validity observation index;
- Secondary Outcome Measures
Name Time Method Safety observation index;