Peginterferon α-2b Injection for Aerosol Therapy in Pediatric Respiratory Syncytial Virus Pneumonia

Last updated: March 11, 2025
Sponsor: West China Second University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv)

Treatment

symptomatic and supportive treatment

Peginterferon α-2b injection

Clinical Study ID

NCT06881056
Y2024033
  • Ages 1-3
  • All Genders

Study Summary

This is a multicenter, randomized, open-label, parallel-controlled, prospective clinical study. It aims to evaluate the efficacy and safety of aerosolized Peginterferon α-2b injection in the treatment of pediatric respiratory syncytial virus pneumonia. The overall study is divided into a screening period, a treatment period, and a follow-up period. Eligible children with respiratory syncytial virus pneumonia will be randomly assigned to the experimental group 1, experimental group 2, and the control group at a ratio of 1:1:1.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1)Age: 1 year ≤ age ≤ 3 years; (2) Gender: Both male and female participants areeligible; (3) According to the 9th edition of "Zhu Fute's Practical Pediatrics,"meet the following diagnostic criteria: a. RSV test positive; b. Clinicalmanifestations: Fever, cough, wheezing; c. Physical signs: Rapid breathing and moistrales in the lungs; (4) Time: The time from the onset of the child's illness to thesigning of the informed consent form is within 72 hours (starting from theoccurrence of any symptom such as fever, cough, or wheezing); (5) Informed consent:The legal guardian of the child understands and signs the informed consent form (ifthe legal guardians are the parents, both parents need to sign together).

Exclusion

Exclusion Criteria:

  • (1) Presence of any of the following clinical symptoms before enrollment: a. Poorgeneral condition, with altered consciousness, refusal to eat, or signs ofdehydration; b. Hypoxemia: Presence of cyanosis, rapid breathing (RR ≥ 50 breathsper minute), stridor, nasal flaring, tracheal tug, oxygen saturation < 92%, andintermittent apnea; c. Extrapulmonary complications; d. Chest X-ray or CT:Multilobar lung infiltrates, pleural effusion, pneumothorax, atelectasis, lungnecrosis, and lung abscess; e. Hyperpyrexia: Persistent high fever for more than 5days; f. Presence of critical complications such as respiratory failure andcirculatory failure; (2) Allergy history and treatment history: a. Receivingantiviral drug treatment with interferon, ribavirin, acyclovir, ganciclovir, orvidarabine monophosphate within 30 days before screening or currently; b. Receivingimmunoglobulin treatment within 30 days before screening or currently; c. Knownhypersensitivity to interferon or its components, or a clear history of otherallergies that make participation in this study inappropriate; d. Use of otherinvestigational drugs within 3 months before screening or within 5 half-lives (whichever is longer), or currently participating in a clinical trial for a medicaldevice at the time of screening; (3) Disease history and current medical history: a.History of congenital heart disease, severe malnutrition, abnormal immune systemfunction, or other serious diseases of major organ systems; b. Severe liver or renaldysfunction; c. History of viral infections such as HBV, HCV, HIV; d. Past orcurrent history of malignant tumors; e. Past history of epilepsy, or history andfamily history of neurological/psychiatric disorders; (4) Other conditions: Subjectsdeemed unsuitable for participation in this trial by the investigator.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: symptomatic and supportive treatment
Phase:
Study Start date:
July 17, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • West China Second University Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

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