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

Last updated: February 9, 2025
Sponsor: Children's Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

Peginterferon α-2b injection

Recombinant Human Interferon α2b

Clinical Study ID

NCT06827249
Peg IFN α- 2b and atomization
  • Ages 6-2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The guardian of the child is able to understand the content, requirements, andlimitations of the protocol, fully understands the possible adverse reactions thatmay occur during the study, is willing to complete the follow-up as required, andvoluntarily 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 thecritical value) at the time of signing the informed consent, and the gender is notspecified.

  3. Positive viral detection in nasopharyngeal swab.

  4. Presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in thelungs; with or without chest imaging showing signs of hyperinflation, patchyinfiltrates, 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 informedconsent form is within 72 hours (the appearance of symptoms and signs related to RSVbronchiolitis 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 beforerandomization.

Exclusion

Exclusion Criteria:

  1. Extreme restlessness, drowsiness, coma, and possibly requiring mechanicalventilation assistance for breathing.

  2. Presence of other chronic severe diseases such as cardiac insufficiency, respiratoryinsufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.

  3. Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, orimmunodeficiency 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 seeAppendix 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 toscreening, or planning to participate in other clinical trials during the studyperiod. (9) A history of pneumonia in the past 3 months.

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

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Peginterferon α-2b injection
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Wuhan Women and Children's Health Care Center

    Wuhan, Hubei
    China

    Site Not Available

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

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