multicenter clinical study on the efficacy and safety of xiyanping injection in the treatment of new coronavirus infection pneumonia (general and severe)

Conditions: COVID-19

Summary: in december 2019, wuhan, in hubei province, china, became the center of an outbreak of pneumonia of unknown cause. in a short time, chinese scientists had shared the genome information of a novel coronavirus (2019-ncov) from these pneumonia patients and developed a real-time reverse transcription pcr (real time rt-pcr) diagnostic assay. in view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by covid-19 can be an alternative target for current treatment. xiyanping injection has anti-inflammatory and immune regulation effects. this study is a randomized, parallel controlled clinical study to treat patients with covid-19 infection.

the new coronavirus (covid-19) \[1\] belongs to the new beta coronavirus. current research shows that it has 85% homology with bat sars-like coronavirus (bat-sl-covzc45), but its genetic characteristics are similar to sarsr-cov. there is a clear difference from mersr-cov. since december 2019, wuhan city, hubei province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. with the spread of the epidemic, as of 12:00 on february 12, 2020, a total of 44726 confirmed cases nationwide (hubei province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in hubei province), and a mortality rate of 2.49% (3.20% in hubei province). in view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by covid-19 can be an alternative target for current treatment. xiyanping injection has anti-inflammatory and immune regulation effects. in the early clinical practice of treating severe h1n1, it was clinically concerned, and combined with conventional treatment, and achieved good results.

Eligibility criteria:
inclusion criteria: 1. aged \>=18 years; 2. novel coronavirus pneumonia patients diagnosed by pathogenic testing; 3. the patient himself participated in the study voluntarily, agreed and signed the informed consent. exclusion criteria: 1. meet the diagnostic criteria for severe new-type coronavirus infection pneumonia; 2. severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and hiv that have not been metastasized in multiple places; 3. obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors; 4. women who are breastfeeding or pregnant; 5. those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies; 6. those who have continued to use immunosuppressive agents or organ transplants in the past 6 months; 7. patients who have participated in other drug clinical trials within 3 months before the screening test; 8. the investigator judges that he or she cannot complete or should not participate in the study (expected death within 48 hours, and the patient refuses active treatment)