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.