Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 426

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with new coronary pneumonia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical recovery time	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	Up to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete fever time	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	Up to Day 14
Cough relief time	Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above	Up to Day 14
Virus negative time	From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)	Up to Day 14
Incidence of severe or critical neocoronavirus pneumonia	Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia	Up to Day 14

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2020
• Primary Completion (Anticipated): July 14, 2020
• Study Completion (Anticipated): December 14, 2021

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Coronavirus Infections; Pneumonia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Immunologic Factors; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Interferons; Interferon-alpha; Interferon-alfa-1b; Ritonavir; Lopinavir
• Other Study ID Numbers: QF-XYP2001-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No