Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

• Conditions: 2019 Novel Coronavirus Pneumonia
• Interventions: Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride; Drug: Xiyanping injection

• Registration Number: NCT04275388
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Status Verified: 2020-04
• Study Start: 2020-05-15
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-20
• Primary Completion: 2020-07-14
• Study Completion: 2021-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 426

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
other drugs	Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride	Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride
Xiyanping injection +other drugs	Xiyanping injection	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 +other drugs	Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride	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

Primary Outcome Measures

Name	Time	Method
Clinical recovery time	Up to Day 14	From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours

Secondary Outcome Measures

Name	Time	Method
Cough relief time	Up to Day 14	Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above
Virus negative time	Up to Day 14	From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Complete fever time	Up to Day 14	From the beginning of research drug use to body temperature \<37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more
Incidence of severe or critical neocoronavirus pneumonia	Up to Day 14	Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia