Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

Qingfeng Pharmaceutical

Status: Unknown

Conditions: 2019 Novel Coronavirus Pneumonia

Treatments: Drug: Xiyanping injection; Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

Study type: Observational

Funder types: Industry

Identifiers

NCT04275388

QF-XYP2001-1

Details and patient eligibility

About

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.

Enrollment: 426 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

426 participants in 2 patient groups

Xiyanping injection +other drugs

Description:

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

Treatment:

Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

Drug: Xiyanping injection

other drugs

Description:

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

Treatment:

Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride