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

NCT03947411 | Unknown

• 1 other identifier: JXQF- XYP-1801
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Influenza

Keywords

severe Influenza

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Signs and Symptoms Score from baseline

  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

  Up to Day 12

Study Arms (2)

Oseltamivir Phosphate+Xiyanping injection

EXPERIMENTAL

Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days

Drug: Xiyanping injection+Oseltamivir Phosphate

Oseltamivir Phosphate treatment only

ACTIVE COMPARATOR

Oseltamivir Phosphate treatment for 7-10 days

Drug: Oseltamivir Phosphate

Interventions

Oseltamivir Phosphate DRUG

Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.

Oseltamivir Phosphate treatment only

Xiyanping injection+Oseltamivir Phosphate DRUG

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.

Oseltamivir Phosphate+Xiyanping injection

Eligibility Criteria

• Age: 3 Years - 6 Years
• Gender Eligibility Details: 3 to 6 years old hospitalized patient
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Xilian Zhang

CONTACT

022-27432299; yfyiec@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: March 4, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CN (1)