Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Jiajun Xu
- Phone Number: 86-18851892277
- Email: xujiajun@kexing.com
Study Contact Backup
- Name: Ling Cao
- Phone Number: 13910610319
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Children's Hospital, Capital Institute of Pediatrics
-
Contact:
- Ling Cao, MD
- Phone Number: 13910610319
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion 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 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:
- 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);
- 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 hours before the administration of administration Children with sugar hormones used in inhalation and body;
- 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 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Human interferon α1b Inhalation Solution (4ug/kg)
Participants will receive Human interferon α1b Inhalation Solution 4ug/kg twice daily for no more than 7 days.
|
Participants will receive Human interferon α1b Inhalation Solution
|
|
Experimental: Human interferon α1b Inhalation Solution(6ug/kg)
Participants will receive Human interferon α1b Inhalation Solution 6ug/kg twice daily for no more than 7 days.
|
Participants will receive Human interferon α1b Inhalation Solution
|
|
Placebo Comparator: Inhalation Solution Placebo
Participants will receive Placebo twice daily for no more than 7 days.
|
Participants will receive Inhalation Solution Placebo
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wang bronchiolitis score chanced by percentage from baseline
Time Frame: day 5
|
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
Time Frame: day 1 to day of last administration (except day 5)
|
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
Time Frame: day 5
|
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
Time Frame: day 5
|
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, the first time the total score reaches < 5 points
Time Frame: day 5
|
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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RSV viral load
Time Frame: From predose to 120 hours postdose
|
qPCR test
|
From predose to 120 hours postdose
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Disease Attributes
- Paramyxoviridae Infections
- Mononegavirales Infections
- Pneumovirus Infections
- Infections
- Communicable Diseases
- Respiratory Tract Infections
- Respiratory Syncytial Virus Infections
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferons
- Pharmaceutical Solutions
Other Study ID Numbers
Other Study ID Numbers
- KXZY-GB05-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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