← Back to Clinical Trials
Recruiting Phase 3 NCT06363370

Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections

Trial Parameters

Condition Respiratory Syncytial Virus Infections
Sponsor Kexing Biopharm Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 322
Sex ALL
Min Age 2 Months
Max Age 2 Years
Start Date 2024-03-27
Completion 2026-06-30
Interventions
Human interferon α1b Inhalation SolutionInhalation Solution Placebo

Brief Summary

To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.

Eligibility Criteria

Inclusion Criteria: 1. 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-\[(37 weeks-fetal age)/4\], gender is not limited; 2. Comply with the following diagnostic criteria: 1\) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and/or asthma, lung auspicious pitch and/or wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and/or thick lung texture/slightly/more and/or emphysema and/or the signs of inflammation around the bronchial. 3\. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the p

Related Trials