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

NCT06827249 | Recruiting

• 1 other identifier: Peg IFN α- 2b and atomization
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Peginterferon α-2b; respiratory syncytial virus

Outcome Measures

Primary Outcomes (1)

• The rate of change in Wang's bronchiolitis score from baseline.

  Day 6.

Secondary Outcomes (9)

• 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

Study Arms (2)

Peginterferon α-2b 90 mcg dose group

EXPERIMENTAL

The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment.

Drug: Peginterferon α-2b injection

Recombinant human interferon α-2b dose group

ACTIVE COMPARATOR

The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b.

Drug: Recombinant Human Interferon α2b

Interventions

Peginterferon α-2b injection DRUG

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.

Peginterferon α-2b 90 mcg dose group

Recombinant Human Interferon α2b DRUG

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.

Recombinant human interferon α-2b dose group

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Soochow University: lead

Study Sites (3)

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

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Chuangli Hao, Ph.D

  Children's Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Chuangli Hao, Ph.D

CONTACT

13771905555; hcl_md@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)