Respiratory Syncytial Virus Infection
Conditions
Interventions
Case series:aerosol inhalation of recombinant human interferon alpha 1b (IFN alpha 1b)
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 5 Years
Inclusion criteria
Inclusion criteria: 1. Aged 2 months to 5 years old; 2. Meet the following diagnostic criteria: (1) Nasopharyngeal swabs tested positive for RSV antigen; (2) Cough, shortness of breath and wheezing, auscultation of the lungs, wheezing and/or rales; (3) The chest radiograph shows signs of spot-like shadows and/or thick lung texture and/or emphysema and/or peribronchitis; 3. Within 72 hours of signing the informed consent form of the child's onset (starting with the onset of any symptoms of fever, cough, shortness of breath, and wheezing); 4. The guardian of the child has a full understanding of the relevant information of this trial and the expected benefits and risks of the subjects, and agrees to the child to participate in the trial and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. People with a history of drug allergy; 2. Those who are known to be allergic to interferon products; 3. People with a history of allergies; 4. Low weight, obesity or growth retardation; 5. A history of premature birth, asthma, severe cardiovascular disease (such as severe congenital heart disease, cardiomyopathy), liver, kidney and other diseases, hemophilia, and a history of pneumonia in the past 3 months; 6. Have a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatomyositis, etc.; 7. Those with basic diseases such as lung, trachea, bronchial dysplasia; 8. Accompanied by epilepsy or other central nervous system dysfunction and disease, such as meningoencephalitis, toxic or hypoxic encephalopathy; 9. Severe diarrhea, moderate malnutrition, anemia (hemoglobin 2 ULN, or total bilirubin> 1.5 times the upper limit of normal; 2) Abnormal blood routine: white blood cell and/or platelet count 12000x109/L or neutrophil ratio>70%; 3) C-reactive protein> 10mg/L; 13. Under the condition of nasal cannula oxygen inhalation (oxygen flow 10 points, or the individual clinical symptoms and signs score is 3 points (according to the pediatric respiratory syncytial virus infectious lower respiratory tract infection disease score scale assessment, appendix 1); 15. Those who are extremely irritable, lethargic, comatose, and may need a ventilator to assist breathing; 16. Have used antiviral chemical drugs such as ribavirin, or antiviral Chinese medicines such as Yanhuning, Xiyanping, or interferon products a week before screening; 17. Participated in other drug clinical trials 3 months before randomization; 18. The researcher thinks it is inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect and safety; | — |
Contacts
Public ContactYingyi Liu
Beijing Triprime co., ltd
Outcome results
None listed