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出境医 / 临床实验 / Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms

Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms

Study Description
Brief Summary:
This is a multicenter, randomized, open Label, add-on study.

Condition or disease Intervention/treatment Phase
Severe Influenza Drug: Oseltamivir Phosphate Drug: Xiyanping injection+Oseltamivir Phosphate Not Applicable

Detailed Description:

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms.

The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Oseltamivir Phosphate+Xiyanping injection
Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days
Drug: Xiyanping injection+Oseltamivir Phosphate
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.

Active Comparator: Oseltamivir Phosphate treatment only
Oseltamivir Phosphate treatment for 7-10 days
Drug: Oseltamivir Phosphate
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.

Outcome Measures
Primary Outcome Measures :
  1. Time to Alleviation of Influenza Signs and Symptoms [ Time Frame: Up to Day 12 ]
    Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.

  2. Duration of Fever [ Time Frame: Up to Day 12 ]
    Length of time taken by participants to return to afebrile state


Secondary Outcome Measures :
  1. Signs and Symptoms Score from baseline [ Time Frame: Up to Day 12 ]
    (1) recovery: symptom score reduction rate ≥ 95%; (2) markedly effective: symptom score reduction rate ≥ 70%; (3) progress: symptom score reduction rate ≥ 30%; (4) invalid: Symptom score reduction rate <30%.

  2. Usage of antibiotic,hormone and incidence of critical cases [ Time Frame: Up to Day 12 ]
  3. Time to Cessation of Viral Shedding by RT-PCR [ Time Frame: Up to Day 12 ]
  4. Relief time of individual symptom such as:expectoration, cough [ Time Frame: Up to Day 12 ]
  5. Disease efficacy criteria [ Time Frame: Up to Day 12 ]
    (1) Healing: The body temperature is normal within 48 hours of treatment, the symptoms disappeared without repetition. (2) markedly effective: the body temperature is normal within 48 hours of treatment, and the symptom score is reduced by more than 2/3. (3) Effective: The body temperature is normal within 72 hours of treatment, and the remaining symptom scores are reduced by 2/3-1/3. (4) Invalid: The condition did not improve or worsened after 72 hours of treatment.

  6. Imaging improvement rate: number of people with normal or baseline imaging [ Time Frame: Up to Day 12 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   3 to 6 years old hospitalized patient
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 3 and 6 years old;
  • Clinical diagnosis of Severe Influenza with hospital treatment needed;
  • Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;

    (1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; (2)Combined pneumonia;

  • The rapid viral antigen test of throat swab and nose swab results were positive;
  • Guardians understood and assigned the informed consent;

Exclusion Criteria:

  • Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate;
  • Creatinine clearance <80ml/min or received continuous renal replacement therapy (CRRT) test;
  • Need extracorporeal membrane oxygenation (ECMO) at baseline;
  • Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline;
  • Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring;
  • Use of systemic steroids or other immunosuppressants;
  • Participants with the following underlying diseases, including: heart disease (such as New York Heart Function Classification II-IV) or clinically significant arrhythmia (such as QTc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( ALT and AST ≥ 1.5 × ULN; Cr and BUN > 1.2 × ULN), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc.
  • Participants used Influenza virus vaccine within 3 months;
  • Participants with drug dependence or with mental disorders within 1 year;
  • Participants participated in other clinical research in the last 30 days;
  • Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.
Contacts and Locations

Contacts
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Contact: Xilian Zhang 022-27432299 yfyiec@163.com

Locations
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China
The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, China
Contact: Xilian Zhang    022-27432299    yfyiec@163.com   
Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
the first affiliated hospital of Liaoning university of traditional Chinese medicine
Beijing Luhe Hospital
Qingdao Municipal Hospital
Cangzhou People's Hospital
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE March 4, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Time to Alleviation of Influenza Signs and Symptoms [ Time Frame: Up to Day 12 ]
    Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.
  • Duration of Fever [ Time Frame: Up to Day 12 ]
    Length of time taken by participants to return to afebrile state
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Signs and Symptoms Score from baseline [ Time Frame: Up to Day 12 ]
    (1) recovery: symptom score reduction rate ≥ 95%; (2) markedly effective: symptom score reduction rate ≥ 70%; (3) progress: symptom score reduction rate ≥ 30%; (4) invalid: Symptom score reduction rate <30%.
  • Usage of antibiotic,hormone and incidence of critical cases [ Time Frame: Up to Day 12 ]
  • Time to Cessation of Viral Shedding by RT-PCR [ Time Frame: Up to Day 12 ]
  • Relief time of individual symptom such as:expectoration, cough [ Time Frame: Up to Day 12 ]
  • Disease efficacy criteria [ Time Frame: Up to Day 12 ]
    (1) Healing: The body temperature is normal within 48 hours of treatment, the symptoms disappeared without repetition. (2) markedly effective: the body temperature is normal within 48 hours of treatment, and the symptom score is reduced by more than 2/3. (3) Effective: The body temperature is normal within 72 hours of treatment, and the remaining symptom scores are reduced by 2/3-1/3. (4) Invalid: The condition did not improve or worsened after 72 hours of treatment.
  • Imaging improvement rate: number of people with normal or baseline imaging [ Time Frame: Up to Day 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Signs and Symptoms Score from baseline [ Time Frame: Up to Day 12 ]
  • Usage of antibiotic,hormone and incidence of critical cases [ Time Frame: Up to Day 12 ]
  • Time to Cessation of Viral Shedding by RT-PCR [ Time Frame: Up to Day 12 ]
  • Relief time of individual symptom such as:expectoration, cough [ Time Frame: Up to Day 12 ]
  • Disease efficacy criteria [ Time Frame: Up to Day 12 ]
  • Imaging improvement rate: number of people with normal or baseline imaging [ Time Frame: Up to Day 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms
Official Title  ICMJE A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms
Brief Summary This is a multicenter, randomized, open Label, add-on study.
Detailed Description

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms.

The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Influenza
Intervention  ICMJE
  • Drug: Oseltamivir Phosphate
    Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
  • Drug: Xiyanping injection+Oseltamivir Phosphate
    Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
Study Arms  ICMJE
  • Experimental: Oseltamivir Phosphate+Xiyanping injection
    Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days
    Intervention: Drug: Xiyanping injection+Oseltamivir Phosphate
  • Active Comparator: Oseltamivir Phosphate treatment only
    Oseltamivir Phosphate treatment for 7-10 days
    Intervention: Drug: Oseltamivir Phosphate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 3 and 6 years old;
  • Clinical diagnosis of Severe Influenza with hospital treatment needed;
  • Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;

    (1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; (2)Combined pneumonia;

  • The rapid viral antigen test of throat swab and nose swab results were positive;
  • Guardians understood and assigned the informed consent;

Exclusion Criteria:

  • Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate;
  • Creatinine clearance <80ml/min or received continuous renal replacement therapy (CRRT) test;
  • Need extracorporeal membrane oxygenation (ECMO) at baseline;
  • Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline;
  • Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring;
  • Use of systemic steroids or other immunosuppressants;
  • Participants with the following underlying diseases, including: heart disease (such as New York Heart Function Classification II-IV) or clinically significant arrhythmia (such as QTc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( ALT and AST ≥ 1.5 × ULN; Cr and BUN > 1.2 × ULN), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc.
  • Participants used Influenza virus vaccine within 3 months;
  • Participants with drug dependence or with mental disorders within 1 year;
  • Participants participated in other clinical research in the last 30 days;
  • Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 3 to 6 years old hospitalized patient
Ages  ICMJE 3 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947411
Other Study ID Numbers  ICMJE JXQF- XYP-1801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study Sponsor  ICMJE Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Collaborators  ICMJE
  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • the first affiliated hospital of Liaoning university of traditional Chinese medicine
  • Beijing Luhe Hospital
  • Qingdao Municipal Hospital
  • Cangzhou People's Hospital
Investigators  ICMJE Not Provided
PRS Account Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP