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

NCT06881056 | Recruiting

• 1 other identifier: Y2024033
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Respiratory Syncytial Virus (RSV); Peginterferon α-2b injection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (3)

Peginterferon α-2b 45 mcg dose group

EXPERIMENTAL

Drug: Peginterferon α-2b injection

Peginterferon α-2b 90 mcg dose group

EXPERIMENTAL

Drug: Peginterferon α-2b injection

Control group

OTHER

Behavioral: symptomatic and supportive treatment

Interventions

Peginterferon α-2b injection DRUG

Peginterferon α-2b injection, 45 mcg, neb.On the 1st, 3rd, and 5th day, take the medication,while providing symptomatic and supportive treatment simultaneously.

Peginterferon α-2b 45 mcg dose group

symptomatic and supportive treatment BEHAVIORAL

symptomatic and supportive treatment

Control group

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (2)

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

RECRUITING

West China Second University Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Study Officials

• Lina Chen, Ph.D

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Chen, Ph.D

CONTACT

028-88570522; chenln66@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: July 17, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)