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

A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Drug: Peginterferon α-2b injection; Drug: Peginterferon α-2b injection; Behavioral: symptomatic and supportive treatment

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Chen, Ph.D; Phone Number: 028-88570522; Email: chenln66@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Chengdu Women's and Children's Central Hospital
      • Contact: Hanmin Liu, Ph.D; Phone Number: 028-85503209; Email: hanmin@vip.163.com
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Second University Hospital of Sichuan University
      • Contact: Lina Chen, Ph.D; Phone Number: 028-88570522; Email: chenln66@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1)Age: 1 year ≤ age ≤ 3 years; (2) Gender: Both male and female participants are eligible; (3) According to the 9th edition of "Zhu Fute's Practical Pediatrics," meet the following diagnostic criteria: a. RSV test positive; b. Clinical manifestations: Fever, cough, wheezing; c. Physical signs: Rapid breathing and moist rales in the lungs; (4) Time: The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (starting from the occurrence 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 (if the legal guardians are the parents, both parents need to sign together).

Exclusion Criteria:

• (1) Presence of any of the following clinical symptoms before enrollment: a. Poor general condition, with altered consciousness, refusal to eat, or signs of dehydration; b. Hypoxemia: Presence of cyanosis, rapid breathing (RR ≥ 50 breaths per minute), stridor, nasal flaring, tracheal tug, oxygen saturation < 92%, and intermittent apnea; c. Extrapulmonary complications; d. Chest X-ray or CT: Multilobar lung infiltrates, pleural effusion, pneumothorax, atelectasis, lung necrosis, and lung abscess; e. Hyperpyrexia: Persistent high fever for more than 5 days; f. Presence of critical complications such as respiratory failure and circulatory failure; (2) Allergy history and treatment history: a. Receiving antiviral drug treatment with interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days before screening or currently; b. Receiving immunoglobulin treatment within 30 days before screening or currently; c. Known hypersensitivity to interferon or its components, or a clear history of other allergies that make participation in this study inappropriate; d. Use of other investigational drugs within 3 months before screening or within 5 half-lives (whichever is longer), or currently participating in a clinical trial for a medical device at the time of screening; (3) Disease history and current medical history: a. History of congenital heart disease, severe malnutrition, abnormal immune system function, or other serious diseases of major organ systems; b. Severe liver or renal dysfunction; c. History of viral infections such as HBV, HCV, HIV; d. Past or current history of malignant tumors; e. Past history of epilepsy, or history and family history of neurological/psychiatric disorders; (4) Other conditions: Subjects deemed unsuitable for participation in this trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	Behavioral: symptomatic and supportive treatment; symptomatic and supportive treatment
Experimental: Peginterferon α-2b 45 mcg dose group	Drug: Peginterferon α-2b injection; Peginterferon α-2b injection, 45 mcg, neb.On the 1st, 3rd, and 5th day, take the medication,while providing symptomatic and supportive treatment simultaneously.; Drug: Peginterferon α-2b injection; Peginterferon α-2b injection, 90 mcg, neb.On the 1st, 3rd, and 5th day, take the medication,while providing symptomatic and supportive treatment simultaneously.
Experimental: Peginterferon α-2b 90 mcg dose group	Drug: Peginterferon α-2b injection; Peginterferon α-2b injection, 45 mcg, neb.On the 1st, 3rd, and 5th day, take the medication,while providing symptomatic and supportive treatment simultaneously.; Drug: Peginterferon α-2b injection; Peginterferon α-2b injection, 90 mcg, neb.On the 1st, 3rd, and 5th day, take the medication,while providing symptomatic and supportive treatment simultaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for the disappearance of major clinical symptoms	Major clinical symptoms include fever, cough, wheezing, increased respiratory rate, and moist rales in the lungs	Day 6
The time of disappearance of abnormal signs.	Abnormal signs include fever, cough, wheezing, increased respiratory rate, and moist rales in the lungs.	Day 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare the differences in treatment efficacy rates among the various groups.	Day 6
Compare the differences in the proportions of primary clinical symptoms alleviated/disappeared among the various groups.	Day3,5.
Compare the differences in the proportions of abnormal physical signs alleviated or disappeared among the various groups.	Day3,5.
Compare the differences in the time curves for the normalization of major clinical symptoms among the various groups.	Day6
Compare the differences in the time curves for the normalization of major abnormal physical signs among the various groups.	Day6
Compare the differences in total hospitalization duration among the various groups.	Day6

Collaborators and Investigators

• Sponsor: West China Second University Hospital
• Investigators: Principal Investigator: Lina Chen, Ph.D, West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus (RSV); Peginterferon α-2b injection
• Other Study ID Numbers: Y2024033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No