Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis

Not Applicable

Recruiting

• Conditions: Bronchiolitis
• Interventions: Drug: Peginterferon α-2b injection; Drug: Recombinant Human Interferon α2b

• Registration Number: NCT06827249
• Lead Sponsor: Children's Hospital of Soochow University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-21
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Start: 2025-03
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Peginterferon α-2b 90 mcg dose group	Peginterferon α-2b injection	The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment.
Recombinant human interferon α-2b dose group	Recombinant Human Interferon α2b	The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b.

Primary Outcome Measures

Name	Time	Method
The rate of change in Wang's bronchiolitis score from baseline.	Day 6.

Secondary Outcome Measures

Name	Time	Method
Wang's bronchiolitis score change from baseline.	Day1-7.
The proportion of Wang's bronchiolitis score being 0 points.	Day6.
Length of hospital stay.	through study completion, an average of 18 months
Duration of oxygen therapy support.	through study completion, an average of 18 months
Change in viral load from baseline.	through study completion, an average of 18 months
Adverse Event(AE).	through study completion, an average of 18 months
Body temperature.	through study completion, an average of 18 months
Number of Participants with Abnormal Laboratory Parameters Findings.	through study completion, an average of 18 months
The number of research subjects who withdrew early.	through study completion, an average of 18 months

Trial Locations

Locations (3)

Wuhan Women and Children's Health Care Center; 🇨🇳 Wuhan, Hubei, China

Children's Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China