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

ConditionBronchiolitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-2
SponsorChildren's Hospital of Soochow University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Peginterferon α-2b 90 mcg dose groupExperimental treatment 1 intervention
Group B: Recombinant human interferon α-2b dose groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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