Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

NCT ID: NCT04275388

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 426 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-12-14

Brief Summary

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.

Conditions

2019 Novel Coronavirus Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Xiyanping injection +other drugs

Drug: Xiyanping injection Xiyanping injection: 10-20ml daily, Qd, the maximum daily dose does not exceed 500mg (20mL) Other drugs: Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride

Xiyanping injection

Intervention Type: DRUG

Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet /Ritonavir tablet or Alpha-interferon nebulization or Abidor Hydrochloride,

Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

Intervention Type: DRUG

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

other drugs

Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride

Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

Intervention Type: DRUG

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

Interventions

Xiyanping injection

Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet /Ritonavir tablet or Alpha-interferon nebulization or Abidor Hydrochloride,

Intervention Type: DRUG

Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);

2. The patient has a complete hospitalization record that can be used for research.

Exclusion Criteria

-

Subjects who meet any of the following criteria cannot be enrolled:

1. Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;

2. People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;

3. According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;

4. Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;

5. Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.

6. The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.

• 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

Central Contacts

Hongzhou Lu, Master

Role: CONTACT

lunliweiyuanhui2009@126.com

021-37990333

Other Identifiers

QF-XYP2001-1

Identifier Type: -

Identifier Source: org_study_id