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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Peginterferon α-2b 90 mcg dose group

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

Group Type EXPERIMENTAL

Peginterferon α-2b injection

Intervention Type 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 α-2b dose group

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

Group Type ACTIVE_COMPARATOR

Recombinant Human Interferon α2b

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No