Official Title
Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)
Brief 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.

Detailed Description

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.

Unknown status
COVID-19

Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection

Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days,

Drug: Lopinavir/ritonavir treatment

Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
NCT Number
MeSH Terms
Pneumonia
Coronavirus Infections
Ritonavir
Lopinavir