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

Not Applicable

• Conditions: COVID-19
• Interventions: Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection; Drug: Lopinavir/ritonavir treatment

• Registration Number: NCT04295551
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Study Start: 2020-03-14
• Primary Completion: 2020-07-14
• Study Completion: 2021-04-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group of ordinary COVID-19	Lopinavir / ritonavir tablets combined with Xiyanping injection	Lopinavir / ritonavir tablets combined with Xiyanping injection
Experimental group of severe COVID-19	Lopinavir / ritonavir tablets combined with Xiyanping injection	Lopinavir / ritonavir tablets combined with Xiyanping injection
Control group of ordinary COVID-19	Lopinavir/ritonavir treatment	ritonavir/ritonavir treatment

Primary Outcome Measures

Name	Time	Method
Clinical recovery time	Up to Day 28	The time from study drug use to complete fever reduction and cough recovery is measured in hours.