Actively Recruiting
Safety and Efficacy of Human Interferon α1b Inhalation Solution for Respiratory Syncytial Virus Lower Respiratory Infection in Children
Led by Kexing Biopharm Co., Ltd. · Updated on 2024-04-12
322
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of human interferon α1b (GB05) inhalation solution in treating children under 2 years old who have respiratory syncytial virus (RSV) infection. This Phase III clinical trial aims to find the best dose and assess how well the treatment works in reducing symptoms of RSV lower respiratory tract infections. Participants will be randomly assigned to one of three groups: one receiving 4 micrograms per kilogram of interferon α1b twice daily, another receiving 6 micrograms per kilogram twice daily, or a placebo group receiving a similar inhalation solution without the active drug. Treatment will be given by nebulization for up to 7 days. After this initial phase, study data will be evaluated to confirm the optimal dose and adjust the sample size for the next study phase. During the study, children will be monitored closely with assessments including the Wang bronchiolitis score measured at day 5 and other days to track symptom changes. Researchers will also measure RSV viral load up to 120 hours after dosing. Parents or guardians will provide informed consent, and the study will observe safety and response to treatment. Participation involves regular study visits and evaluations over the treatment period with follow-up to ensure safety and gather data on treatment effects.
CONDITIONS
Brief Title
Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 2 months and 2 years (including corrected age for premature babies), any gender
- Positive test for respiratory syncytial virus (RSV) by PCR or quantitative QPCR
- Presence of cough and/or wheezing with lung sounds like crackles or wet noises
- Chest imaging showing lung changes such as dot-shaped shadows, thickened lung texture, emphysema, or signs of bronchial inflammation
- Onset of symptoms including cough, breathing issues, or fever within 72 hours
- Moderate to severe bronchiolitis severity
- Parent or legal guardian has signed informed consent after understanding the study and possible risks
You will not qualify if you...
- History of allergies to interferon, related compounds, or multiple drug/food/pollen allergies
- Inability to tolerate nebulized inhalation or severe oral/maxillofacial deformities affecting inhalation
- Presence of genetic metabolic diseases
- Infection with other respiratory pathogens
- Use of certain antiviral drugs, interferon, or corticosteroids within specified timeframes before treatment
- Severe cardiovascular diseases such as congenital heart disease or myocardial disease
- History of liver, kidney, or blood clotting disorders
- History of autoimmune diseases like autoimmune hemolytic anemia, thyroid autoimmune disease, or dermatitis
- Chronic lung or bronchial diseases
- Neurological conditions such as epilepsy, meningitis, or toxic/hypoxic encephalopathy
- Severe diarrhea, moderate malnutrition, anemia, or blood system diseases during screening
- Presence of thoracic effusion, pus, or mold infection during screening
- Abnormal laboratory results suggesting bacterial infection or liver function issues
- Severe irritability, drowsiness, coma, or need for ventilator support
- Known or suspected HIV infection
- Participation in any drug clinical trial or use of investigational drugs within 30 days before enrollment
- Inability to complete the study or judged unsuitable by researchers for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive inhaled Human interferon α1b solution or placebo twice daily for no more than 7 days to treat respiratory syncytial virus infection.
Daily visits or assessments during treatment period
Trial Site Locations
Total: 1 location
1
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
J
Jiajun Xu
L
Ling Cao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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