A randomized, open-label, blank-controlled, multicenter trial for Shuang-Huang-Lian oral solution in the treatment of ovel coronavirus pneumonia (COVID-19)
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2000002975
- Lead Sponsor
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with confirmed new coronavirus-infected pneumonia;
2. Above 18 years old (inclusive);
3. Voluntarily sign written informed consent.
1. Severe pneumonia requires mechanical ventilationcritically severe cases;
2. Estimated Time of Death is less than 48 hours;
3. 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;
4. 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;
5. 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 .;
6. Mental state unable to cooperate, suffering from mental illness, unable to control, unable to express clearly
7. 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;
8. Patients with a history of substance abuse or dependence;
9. Pregnant or lactating women;
10. Patients who participated in other clinical trials within the last 3 months;
11. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to disease recovery;
- Secondary Outcome Measures
Name Time Method Biochemical Indicators;Clearance rate and time of main symptoms (fever, fatigue, cough);Time and rate of coronavirus become negative;immune indices;Routine blood test;Exacerbation (transfer to RICU) time;