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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.
The study has been divided into two parts, 60 subjects will be randomly assigned to the 4μg/kg dose group or 6μg/kg dose group or the blank control group, to receive nebulized GB05 therapy, twice daily for no more than 7 days. After comprehensive evaluation of effectiveness and safety, and confirmation of the optimal dose, the sample size will be re-calculated to enter the second part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human interferon α1b Inhalation Solution (4ug/kg) | Experimental | Participants will receive Human interferon α1b Inhalation Solution 4ug/kg twice daily for no more than 7 days. |
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| Human interferon α1b Inhalation Solution(6ug/kg) | Experimental | Participants will receive Human interferon α1b Inhalation Solution 6ug/kg twice daily for no more than 7 days. |
|
| Inhalation Solution Placebo | Placebo Comparator | Participants will receive Placebo twice daily for no more than 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human interferon α1b Inhalation Solution | Drug | Participants will receive Human interferon α1b Inhalation Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wang bronchiolitis score chanced by percentage from baseline | The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe. | day 5 |
| Wang bronchiolitis score chanced by percentage from baseline | The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe. | day 1 to day of last administration (except day 5) |
| Wang bronchiolitis score of 0 in proportion | The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe. | day 5 |
| Wang bronchiolitis score total score < 5 points | The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe. | day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| RSV viral load | qPCR test | From predose to 120 hours postdose |
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Inclusion 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajun Xu | Contact | 86-18851892277 | xujiajun@kexing.com | |
| Ling Cao | Contact | 13910610319 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Capital Institute of Pediatrics | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Inhalation Solution Placebo | Drug | Participants will receive Inhalation Solution Placebo |
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| Wang bronchiolitis score, the first time the total score reaches < 5 points | The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe. | day 5 |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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