Clinical trial NCT03947411: Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Influenza
Keywords: severe Influenza
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Beijing Luhe Hospital
name: Qingdao Municipal Hospital
name: Cangzhou People's Hospital
First posted: 2019-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Time to Alleviation of Influenza Signs and Symptoms
timeFrame: Up to Day 12
measure: Duration of Fever
timeFrame: Up to Day 12
Secondary outcomes:
measure: Signs and Symptoms Score from baseline
timeFrame: Up to Day 12
measure: Usage of antibiotic,hormone and incidence of critical cases
timeFrame: Up to Day 12
measure: Time to Cessation of Viral Shedding by RT-PCR
timeFrame: Up to Day 12
measure: Relief time of individual symptom such as:expectoration, cough
timeFrame: Up to Day 12
measure: Disease efficacy criteria
timeFrame: Up to Day 12
measure: Imaging improvement rate: number of people with normal or baseline imaging
timeFrame: Up to Day 12
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
References: