Treatment of pediatric bronchiolitis with Peginterferon α-2b injection

A Multicenter, Randomized, Positive-controlled, Non-inferiority Clinical Study to Evaluate the Safety and Efficacy of Peginterferon α2b Injection in the Treatment of Pediatric RSV Bronchiolitis

This study is testing if an injection of Peginterferon α-2b can safely help young children with bronchiolitis caused by RSV feel better compared to a different treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 6 Months to 2 Years
• Sex: All
• Sponsor: Children's Hospital of Soochow University (Academic / other)
• Locations: 3 sites (Wuhan, Hubei and 2 other locations)
• Trial ID: NCT06827249 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection in treating bronchiolitis caused by respiratory syncytial virus (RSV) in children aged 6 months to 2 years. It is a multicenter, randomized, positive-controlled, non-inferiority study that plans to enroll 90 participants. The trial will compare the effects of Peginterferon α-2b with recombinant human interferon α2b, focusing on the severity of symptoms and overall health outcomes. Participants will be monitored for adverse reactions and follow-up care will be provided as required.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 months to 2 years who have been diagnosed with mild to moderate bronchiolitis due to RSV.

Not a fit: Patients with severe bronchiolitis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing bronchiolitis in young children, potentially reducing hospitalizations and improving recovery times.

How similar studies have performed: While there have been studies on RSV treatments, the specific use of Peginterferon α-2b in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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.
3. Positive viral detection in nasopharyngeal swab.
4. 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.
5. The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
6. 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).
7. No use of other antiviral drugs or immunomodulators within 3 weeks before randomization.

Exclusion Criteria:

1. Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing.
2. Presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.
3. Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases.
4. Having epilepsy or other disorders of central nervous system function.
5. The investigator's comprehensive judgment suspects a concurrent bacterial infection.
6. Clinical diagnosis of myocarditis or suspected myocarditis (diagnostic criteria see Appendix 2: Diagnostic Recommendations for Myocarditis in Children).
7. Known or suspected allergy to interferon or excipients.
8. 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.

(10) Other conditions deemed unsuitable for inclusion by the investigator.

Where this trial is running

Wuhan, Hubei and 2 other locations

• Wuhan Women and Children's Health Care Center — Wuhan, Hubei, China (Not_yet_recruiting)
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Chuangli Hao, Ph.D — Children's Hospital of Soochow University
• Study coordinator: Chuangli Hao, Ph.D

Conditions Bronchiolitis; Peginterferon α-2b; respiratory syncytial virus