Aerosolized Peginterferon α-2b for treating RSV pneumonia in young children
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 study is testing if a new inhaled treatment can help young children with RSV pneumonia feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Year to 3 Years |
| Sex | All |
| Sponsor | West China Second University Hospital Academic / other |
| Locations | 2 sites (Chengdu, Sichuan and 1 other locations) |
| Trial ID | NCT06881056 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of aerosolized Peginterferon α-2b injection in treating pediatric patients with respiratory syncytial virus (RSV) pneumonia. It is a multicenter, randomized, open-label study where eligible children aged 1 to 3 years will be assigned to one of three groups: two experimental groups receiving the treatment and one control group. The study includes a screening period, a treatment period, and a follow-up period to monitor outcomes. The trial aims to provide insights into a new therapeutic approach for a common viral infection in children.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 3 years who test positive for RSV and exhibit specific clinical symptoms.
Not a fit: Patients with severe clinical symptoms or poor general condition prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for children suffering from RSV pneumonia.
How similar studies have performed: While this approach is novel, similar studies have explored antiviral treatments for RSV, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chengdu, Sichuan and 1 other locations
- 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 contacts
- Principal investigator: Lina Chen, Ph.D — West China Second University Hospital
- Study coordinator: Lina Chen, Ph.D
- Email: chenln66@163.com
- Phone: 028-88570522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.