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New treatment option for Respiratory Syncytial Virus Infections
Official title Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
ClinicalTrials.gov ID: NCT06363370
What this study is testing
What is Human interferon α1b Inhalation Solution?
Human interferon α1b Inhalation Solution is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for respiratory syncytial virus infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 2
You may be able to join if
- 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth...
- Comply with the following diagnostic criteria: 1) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative...
You likely can't join if
- There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies...
- Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of...
- Those who have genetic metabolic diseases;
- A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；
- Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to...
- There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.
See the full eligibility criteria
- 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;
- 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...
- 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...
- Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation;
- Those who have genetic metabolic diseases;
- A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；
- 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...
- There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.
- There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.;
- Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia;
- Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy;
- During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease;
- During the screening, the thoracic effusion, pydion and pus, and pus, etc.;
- Merce able goose sores suspected mold infection during screening；
- 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...
- Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing;
- 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;
- In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.