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Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04275388
Recruitment Status : Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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

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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
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




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


Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

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


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

Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Interferons
Ritonavir
Lopinavir
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV 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
Physiological Effects of Drugs