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NCT Number: NCT06827249

Peginterferon α-2b Injection for 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.

Recruiting

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Key information

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Day 6.

Secondary outcomes

  1. Wang's bronchiolitis score change from baseline.

    Time frame: Day1-7.

  2. The proportion of Wang's bronchiolitis score being 0 points.

    Time frame: Day6.

  3. Length of hospital stay.

    Time frame: through study completion, an average of 18 months

  4. Duration of oxygen therapy support.

    Time frame: through study completion, an average of 18 months

  5. Change in viral load from baseline.

    Time frame: through study completion, an average of 18 months

  6. Adverse Event(AE).

    Time frame: through study completion, an average of 18 months

  7. Body temperature.

    Time frame: through study completion, an average of 18 months

  8. Number of Participants with Abnormal Laboratory Parameters Findings.

    Time frame: through study completion, an average of 18 months

  9. The number of research subjects who withdrew early.

    Time frame: through study completion, an average of 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Chuangli Hao, Ph.D

CONTACT

[email protected]

13771905555

Sponsors and collaborators

Lead sponsor

Children's Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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