Clinical trial NCT06827249: Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Peginterferon α-2b
respiratory syncytial virus
Lead sponsor: Children's Hospital of Soochow University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of change in Wang's bronchiolitis score from baseline.
timeFrame: Day 6.
Secondary outcomes:
measure: Wang's bronchiolitis score change from baseline.
timeFrame: Day1-7.
measure: The proportion of Wang's bronchiolitis score being 0 points.
timeFrame: Day6.
measure: Length of hospital stay.
timeFrame: through study completion, an average of 18 months
measure: Duration of oxygen therapy support.
timeFrame: through study completion, an average of 18 months
measure: Change in viral load from baseline.
timeFrame: through study completion, an average of 18 months
measure: Adverse Event(AE).
timeFrame: through study completion, an average of 18 months
measure: Body temperature.
timeFrame: through study completion, an average of 18 months
measure: Number of Participants with Abnormal Laboratory Parameters Findings.
timeFrame: through study completion, an average of 18 months
measure: The number of research subjects who withdrew early.
timeFrame: through study completion, an average of 18 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Women and Children's Health Care Center
state: Hubei
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Children's Hospital of Soochow University
name: Chuangli Hao, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Fanzheng Meng, Ph.D
role: STUDY_DIRECTOR
affiliation: Wuhan women and children's health care center
name: Xiaoxia Lu, Ph.D
role: STUDY_DIRECTOR
References: