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

NCT ID: NCT04295551

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-14
• Study Completion Date: 2021-04-14

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group of ordinary COVID-19

Lopinavir / ritonavir tablets combined with Xiyanping injection

Group Type: EXPERIMENTAL

Lopinavir / ritonavir tablets combined with Xiyanping injection

Intervention Type: DRUG

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,

Control group of ordinary COVID-19

ritonavir/ritonavir treatment

Group Type: ACTIVE_COMPARATOR

Lopinavir/ritonavir treatment

Intervention Type: DRUG

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

Experimental group of severe COVID-19

Lopinavir / ritonavir tablets combined with Xiyanping injection

Group Type: EXPERIMENTAL

Lopinavir / ritonavir tablets combined with Xiyanping injection

Intervention Type: DRUG

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,

Interventions

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,

Intervention Type: DRUG

Lopinavir/ritonavir treatment

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

QF-XYP1990-1

Identifier Type: -

Identifier Source: org_study_id