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Evaluation of the Efficacy and Safety of Nebulized Recombinant Human Interferon a1b Injection in the Treatment of Pediatric Viral Pneumonia: A Multicenter, Randomized, Open-Label, Controlled Clinical Study

Evaluation of the Efficacy and Safety of Nebulized Recombinant Human Interferon a1b Injection in the Treatment of Pediatric Viral Pneumonia: A Multicenter, Randomized, Open-Label, Controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113687
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-12-20
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Viral Pneumonia

Interventions

Control Group:Symptomatic Treatment
Experimental Group:Symptomatic Treatment and interferon nebulization.

Sponsors

Fujian Children's Hospital,Jin'an District, Fuzhou City,Fujian Province, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 2 months to 14 years, inclusive, of either sex; 2. Meeting the diagnostic criteria for pediatric community-acquired pneumonia as defined by the "Management Guidelines for Pediatric Community-Acquired Pneumonia (2024 Revision)".

Exclusion criteria

Exclusion criteria: Those with any of the following conditions should be excluded and excluded from inclusion: 1. Known to be allergic to interferon products; 2. Those with a history of anaphylaxis [A history of anaphylaxis was defined as anaphylaxis of grade 2 or above, in which any of the following clinical manifestations occurred: Airway obstruction (stridor, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory and cardiac arrest]; 3. Underweight, obesity or growth retardation, height and weight not between -1SD and 1SD for the same age and sex; 4. Asthma history, serious cardiovascular, liver, kidney, hemophilia, autoimmune diseases, respiratory tract dysplasia history, epilepsy or other central nervous system dysfunction and lesions, and pneumonia in the past 3 months; 5. Abnormal laboratory tests during screening: (1) liver function tests: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times of the upper limit of normal value, or total bilirubin > 1.5 times of the upper limit of normal value; (2) Blood routine: white blood cell count 10mg/L, or procalcitonin (PCT) > 0.5µg/L, or the investigator's comprehensive judgment of suspected bacterial infection; 6, screening under the condition of nasal cannula oxygen (oxygen flow <2L/min), percutaneous oxygen saturation (SatO2) < 92% or without oxygen, SatO2< 88%; 7. Extreme restlessness, lethargy, coma, disturbance of consciousness, need to be admitted to ICU, and may need ventilator assisted breathing; 8. Participated in other drug clinical trials 3 months before randomization; 9. Outpatient treatment; 10. Those who were considered unsuitable to participate in the trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Duration of fever;Duration of cough;Duration of wheezing;Length of hospital stay;

Secondary

MeasureTime frame
Hospitalization Costs;Recurrence Rate;Duration of Oxygen Therapy;

Countries

Chian

Contacts

Public ContactTang Qiuyu

Fujian Children's Hospital

tellrain211@126.com+86 189 5035 6150

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026