Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

• ClinicalTrials.gov Identifier: NCT04275388
• Recruitment Status: Unknown
• First Posted: February 19, 2020
• Last Update Posted: May 20, 2020
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Information provided by (Responsible Party): Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study Description

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.

Condition or disease	Intervention/treatment
2019 Novel Coronavirus Pneumonia	Drug: Xiyanping injection; Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

Study Design

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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	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	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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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)
4. 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

routine blood test

Eligibility Criteria

• 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

Study Population

Patients diagnosed with new coronary pneumonia

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.

Contacts and Locations

Contacts

Contact: Hongzhou Lu, Master; 021-37990333; lunliweiyuanhui2009@126.com

Sponsors and Collaborators

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

More Information

• Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04275388
• Other Study ID Numbers: QF-XYP2001-1
• First Posted: February 19, 2020
• 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

Additional relevant MeSH terms:

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