Inhaled interferon α1b treatment for RSV in young children
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.
Run by Kexing Biopharm Co., Ltd. · NCT06363370 · Data updated 2026-11-12
This study is testing a new inhaled treatment for RSV in young children under 2 years old to see if it helps them get better and is safe to use.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Months to 2 Years |
| Sex | All |
| Enrollment | 322 (estimated) |
| Sponsor | Kexing Biopharm Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 27, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06363370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 2 months to 2 years who have confirmed RSV infections and exhibit moderate to severe symptoms.
✕Probably not a fit
Patients with mild RSV infections or those outside the specified age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of inhaled interferon α1b (GB05) in treating respiratory syncytial virus (RSV) infections in children under 2 years old. The study is divided into two parts, with 60 subjects randomly assigned to receive either a 4μg/kg or 6μg/kg dose of the treatment or a placebo, administered twice daily for up to 7 days. The first part focuses on determining the optimal dose based on effectiveness and safety evaluations, followed by a recalculation of sample size for the second part of the study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for young children suffering from severe RSV infections.
How similar studies have gone: Other studies have explored antiviral treatments for RSV, but the specific use of inhaled interferon α1b is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-\[(37 weeks-fetal age)/4\], gender is not limited; 2. Comply with the following diagnostic criteria: 1\) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and/or asthma, lung auspicious pitch and/or wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and/or thick lung texture/slightly/more and/or emphysema and/or the signs of inflammation around the bronchial. 3\. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the possible benefits and risks of the subject's expectations, and agreed that the child to participate in this experiment and voluntarily signed the informed consent. Exclusion Criteria: 1. There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies (asthma, based on the "eczema area and severity index" (EASI for short) scoring method as severe eczema, etc.), Or those who are diagnosed by doctors clearly diagnose (such as allergies to two or more drugs, food and pollen); 2. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation; 3. Those who have genetic metabolic diseases; 4. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen); 5. Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to specify the Chinese medicines with antiviral effects, etc.) and within 24 hours before the administration of administration Children with sugar hormones used in inhalation and body; 6. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia. 7. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.; 8. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia; 9. Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy; 10. During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease; 11. During the screening, the thoracic effusion, pydion and pus, and pus, etc.; 12. Merce able goose sores suspected mold infection during screening; 13. The laboratory inspection is abnormal during screening:1) White blood cell count\>14x109/L (or normal value of normal value) or neutral granulocyte ratio\> 70%, and researchers comprehensively judge suspects as merging bacterial infections;2) Excisibility of liver function test: Alanine aminotransferase (ALT) or permine aminamidase (AST)\> The upper limit of the normal value is 2 times, or the total biliary erythrin\> 1.5 times the upper limit of the normal value;3) Blood routine abnormalities: white blood cell count \<3.5X109/L and/or platelet count≤100x109/L; 14. Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing; 15. After the history of the history of the disease, the child known (or the mother who is younger than 6 months old) is HIV -positive, or the researcher is highly suspected of being HIV -positive; 16. In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs; 17. Volunteers may not be able to complete this study or researchers who believe that they are not suitable for participating in this clinical trial due to various reasons.
Where it's running
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Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Jiajun Xu
- Email: xujiajun@kexing.com
- Phone: 86-18851892277
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ziresovir (AK0529) for high-risk adults with RSV infection
This study tests whether Ziresovir can shorten RSV-related lower respiratory tract illness in high-risk adults compared with placebo.
-
Recombinant RSV Vaccine (CHO Cell) with Adjuvant in Adults 18+ in China
This is a two-part study testing a recombinant RSV vaccine in adults to see if it is safe and whether it provokes an immune response, with older adults (60+) included in the second part.
-
RSV strains and illness burden in Vietnamese adults aged 60 and older
This project will test how common RSV is and which strains and severity patterns occur in people aged 60+ who are hospitalized with acute respiratory illness or worsening heart/lung disease.
-
S-337395 for high-risk adults with symptomatic RSV
This trial will test whether taking the antiviral S-337395 within 72 hours of symptoms helps nonhospitalized adults with RSV who are at high risk of progressing to severe illness.
-
Evaluating a new treatment to prevent severe COVID-19 complications
This study is testing a new treatment to see if it can help hospitalized COVID-19 patients avoid severe complications caused by inflammation.
-
Identifying biomarkers linked to severity in adults with RSV infections
This study is trying to find specific markers in the body that can help doctors understand how severe Respiratory Syncytial Virus (RSV) infections are in adults who are hospitalized.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.