Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Clinical recovery time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >=18 years;
- •Novel coronavirus pneumonia patients diagnosed by pathogenic testing;
- •The patient himself participated in the study voluntarily, agreed and signed the informed consent.
排除标准
- •Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
- •Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
- •Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
- •Women who are breastfeeding or pregnant;
- •Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
- •Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months;
- •Patients who have participated in other drug clinical trials within 3 months before the screening test;
- •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)
研究组 & 干预措施
Experimental group of ordinary COVID-19
Lopinavir / ritonavir tablets combined with Xiyanping injection
干预措施: Lopinavir / ritonavir tablets combined with Xiyanping injection (Drug)
Control group of ordinary COVID-19
ritonavir/ritonavir treatment
干预措施: Lopinavir/ritonavir treatment (Drug)
Experimental group of severe COVID-19
Lopinavir / ritonavir tablets combined with Xiyanping injection
干预措施: Lopinavir / ritonavir tablets combined with Xiyanping injection (Drug)
结局指标
主要结局
Clinical recovery time
时间窗: Up to Day 28
The time from study drug use to complete fever reduction and cough recovery is measured in hours.
次要结局
未报告次要终点