Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

2019 Novel Coronavirus Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04275388
• Other study ID #: QF-XYP2001-1
• Status: Not yet recruiting
• Start date: May 15, 2020
• Est. completion date: December 14, 2021

Study information

• Verified date: April 2020
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Hongzhou Lu, Master
• Phone: 021-37990333
• Email: lunliweiyuanhui2009[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 426
• Est. completion date: December 14, 2021
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• 2019 Novel Coronavirus Pneumonia
• Coronavirus Infections
• Pneumonia

Intervention

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,
• Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride
Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization;Abidor Hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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