Overview

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

Status:
Unknown status
Trial end date:
2020-03-31
Target enrollment:
0
Participant gender:
All
Summary
This is a multicenter, randomized, open Label, add-on study.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Collaborators:
Beijing Luhe Hospital
Cangzhou People's Hospital
Qingdao Municipal Hospital
the first affiliated hospital of Liaoning university of traditional Chinese medicine
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Treatments:
Oseltamivir
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.