Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia
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ClinicalTrials.gov Identifier: NCT04275388 |
Recruitment Status : Unknown
Verified April 2020 by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Recruitment status was: Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : May 20, 2020
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Condition or disease | Intervention/treatment |
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2019 Novel Coronavirus Pneumonia | Drug: Xiyanping injection Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride |
Study Type : | Observational |
Estimated Enrollment : | 426 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type) |
Estimated Study Start Date : | May 15, 2020 |
Estimated Primary Completion Date : | July 14, 2020 |
Estimated Study Completion Date : | December 14, 2021 |
Group/Cohort | Intervention/treatment |
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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
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Drug: 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, 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 |
other drugs
Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride
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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 |
- Clinical recovery time [ Time Frame: 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
- Complete fever time [ Time Frame: 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
- Cough relief time [ Time Frame: 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 [ Time Frame: Up to Day 14 ]From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
- Incidence of severe or critical neocoronavirus pneumonia [ Time Frame: Up to Day 14 ]Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia
Biospecimen Retention: None Retained

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Ages Eligible for Study: | up to 100 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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);
- The patient has a complete hospitalization record that can be used for research.
Exclusion Criteria:
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Subjects who meet any of the following criteria cannot be enrolled:
- 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;
- 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;
- 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;
- Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
- Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.
- The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275388
Contact: Hongzhou Lu, Master | 021-37990333 | lunliweiyuanhui2009@126.com |
Responsible Party: | Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT04275388 |
Other Study ID Numbers: |
QF-XYP2001-1 |
First Posted: | February 19, 2020 Key Record Dates |
Last Update Posted: | May 20, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Coronavirus Infections COVID-19 Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Pneumonia, Viral Interferons Ritonavir Lopinavir |
Interferon-alpha Interferon-alfa-1b Antineoplastic Agents Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Immunologic Factors |