Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis (NCT06827249) | Clinical Trial Compass
RecruitingNot Applicable
Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
China90 participantsStarted 2025-03
Plain-language summary
This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.
Who can participate
Age range
6 Months – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse reactions that may occur during the study, is willing to complete the follow-up as required, and voluntarily signs the informed consent form before the start of the study.
. The child's age is 6 months or older but no more than 2 years old (including the critical value) at the time of signing the informed consent, and the gender is not specified.
. Positive viral detection in nasopharyngeal swab.
. Presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in the lungs; with or without chest imaging showing signs of hyperinflation, patchy infiltrates, localized atelectasis, and peribronchitis.
. The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of change in Wang's bronchiolitis score from baseline.
. The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (the appearance of symptoms and signs related to RSV bronchiolitis does not exceed 72 hours from the signing of the informed consent, including but not limited to: tachypnea, wheezing, hypoxemia, dyspnea, fever).
. No use of other antiviral drugs or immunomodulators within 3 weeks before randomization.
Exclusion criteria
. Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing.
. Presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.
. Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases.
. Having epilepsy or other disorders of central nervous system function.
. The investigator's comprehensive judgment suspects a concurrent bacterial infection.
. Clinical diagnosis of myocarditis or suspected myocarditis (diagnostic criteria see Appendix 2: Diagnostic Recommendations for Myocarditis in Children).
. Known or suspected allergy to interferon or excipients.
. Participation in other interventional clinical trials within 3 months prior to screening, or planning to participate in other clinical trials during the study period. (9) A history of pneumonia in the past 3 months.