Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Bromhexine Hydrochloride Tablets + Standard treatment
Control group:Standard treatment
Sponsors
Children's Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 2 and 18 years male or female; 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of COVID-19, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6) ". Or the patients with negative 2019-nCoV RNA results but clinical symptoms suspected; 3. The legal guardian of the enrolled children shall sign the informed consent voluntarily (subjects >=8 years old shall sign the informed consent voluntarily).
Exclusion criteria
Exclusion criteria: 1. Excluded who diagnosed as pneumonia patients with novel coronavirus infection of severe type and critical type. Diagnostic criteria reference the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"; 2. Patients with allergic to the ingredients of bromhexine hydrochloride tablets and/or definite contraindications in the label of bromhexine hydrochloride tablets. 3. The researchers determined that the participants were not suitable for this clinical trial (e.g., children with multiple underlying diseases who may be transferred to hospital for treatment during the study period). 4. Past or present combined with any of the following major disease history or impact study assessments: (1) History of serious cardiovascular and cerebrovascular diseases, such as heart failure, congenital heart disease, serious arrhythmia and cerebrovascular accident; (2) Patients with severe liver disease or liver insufficiency, such as cirrhosis, chronic active hepatitis; (3) Patients with severe kidney disease (such as chronic renal insufficiency); (4) History of malignant tumor; (5) Patients with serious hematopoietic diseases or agranulocytosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of aggravation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission rate;Time and rate of laboratory indicators related to disease improvement to return to normal;Rate of patients with fever;Rate of patients with dyspnea;Rate of patients with requring supplemental oxygen;Rate of patients with mechanical ventilation;Rate of ICU admission;Rate of negative 2019-nCoV RNA results;The change of viral load and the time when the viral nucleic acid turns negative; | — |
Countries
China
Contacts
Public ContactZhimin Chen
Children's Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed