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

A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms

This is a multicenter, randomized, open Label, add-on study.

Study Overview

• Status: Unknown
• Conditions: Severe Influenza
• Intervention / Treatment: Drug: Xiyanping injection+Oseltamivir Phosphate; Drug: Oseltamivir Phosphate

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: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine
    • Contact: Xilian Zhang; Phone Number: 022-27432299; Email: yfyiec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Alleviation of Influenza Signs and Symptoms	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.	Up to Day 12
Duration of Fever	Length of time taken by participants to return to afebrile state	Up to Day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs and Symptoms Score from baseline	(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%.	Up to Day 12
Usage of antibiotic,hormone and incidence of critical cases		Up to Day 12
Time to Cessation of Viral Shedding by RT-PCR		Up to Day 12
Relief time of individual symptom such as:expectoration, cough		Up to Day 12
Disease efficacy criteria	(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.	Up to Day 12
Imaging improvement rate: number of people with normal or baseline imaging		Up to Day 12

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Collaborators: Qingdao Municipal Hospital; Beijing Luhe Hospital; Cangzhou People's Hospital; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2019
• Primary Completion (ANTICIPATED): March 31, 2020
• Study Completion (ANTICIPATED): March 31, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: severe Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: JXQF- XYP-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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