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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Drug: Peginterferon α-2b injection; Drug: Recombinant Human Interferon α2b

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuangli Hao, Ph.D; Phone Number: 13771905555; Email: hcl_md@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Wuhan Women and Children's Health Care Center
      • Contact: Xiaoxia Lu, Ph.D
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • Children's Hospital of Soochow University
      • Contact: Chuangli Hao, Ph.D; Email: hcl_md@163.com
  • Jilin
    • Changchun, Jilin, China
      • Not yet recruiting
      • The First Hospital of Jilin University
      • Contact: Fanzheng Meng, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peginterferon α-2b 90 mcg dose group; The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment.	Drug: Peginterferon α-2b injection; Peginterferon α-2b injection, 90 mcg, on the basis of conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, nebulized inhalation using air compression or oxygen-driven methods is administered on days 1, 3, and 5, once a day.
Active Comparator: Recombinant human interferon α-2b dose group; The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b.	Drug: Recombinant Human Interferon α2b; Recombinant Human Interferon alpha 2b, at a dose of 100,000 IU/kg, based on the conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, will be administered via nebulized inhalation using air compression or oxygen-driven methods from day 1 to day 5, twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of change in Wang's bronchiolitis score from baseline.	Day 6.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Soochow University
• Investigators: Principal Investigator: Chuangli Hao, Ph.D, Children's Hospital of Soochow University; Study Director: Fanzheng Meng, Ph.D, The First Hospital of Jilin University; Study Director: Xiaoxia Lu, Ph.D, Wuhan Women and Children's Health Care Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Bronchiolitis; respiratory syncytial virus; Peginterferon α-2b
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Anti-Infective Agents; Antineoplastic Agents; Antiviral Agents; Interferons
• Other Study ID Numbers: Peg IFN α- 2b and atomization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No