- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05859984
To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children
May 7, 2023 updated by: Seventh Medical Center of PLA General Hospital
A Prospective, Randomized, Double-blind, Double-simulated, Placebo Parallel-controlled, Multicenter Clinical Study on Safety and Efficacy of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children
To evaluate the clinical efficacy and safety of recombinant human interferon ω spray in treatment of viral upper respiratory tract infection in children aged by 3-12 years, and to explore the appropriate usage and dosage of the drug in treatment of upper respiratory tract infection caused by viruses.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multi-center clinical study.
Children who met the inclusion criteria of viral upper respiratory tract infection in eligible children aged by 3-12 years will be enrolled.
The study contained 3 treatment groups.
Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli were used as symptomatic treatment drugs in each group, and the two test groups additionally added to different doses of recombinant human interferon ω spray, placebo was added to the placebo group.
This study is a prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multi-center clinical study.
Children who met the inclusion criteria of viral upper respiratory tract infection in eligible children aged by 3-12 years will be enrolled.
The study contained 3 treatment groups.
Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli were used as symptomatic treatment drugs in each group, and the two test groups additionally added to different doses of recombinant human interferon ω spray, placebo was added to the placebo group.
In each group, each bottle of drug was sprayed 1 time, sprayed into the child's pharynx, 2 times/dayand should not eat or drink for 20 minutes after using the medicine, Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli should be taken orally according to the doctor's instructions.
The treatment period is 7 days.
All subjects returned to the study site for evaluating the primary efficacy measures, secondary efficacy measures and safety measures on Treatment Day 7±1.
Telephone follow-up was performed on Treatment Day 14±2.
Study Type
Interventional
Enrollment (Anticipated)
345
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhichun Feng, M.M
- Phone Number: +86(10) 66721786
- Email: zhjfengzc@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 3 years old ≤ age ≤ 12 years old, gender unlimited;
- Routine blood test of white cells < Upper limit of normal value, C reactive protein < Upper limit of normal value. Meeting the description of the diagnostic criteria for viral upper respiratory tract infection in Zhufutang Practical Pediatrics;
- Body temperature ≥ 38 ℃(axillary temperature);
- The guardian should give informed consent and sign the informed consent form (if the child is ≥ 10 years old, the child should also give informed consent and sign the informed consent form).
Exclusion Criteria:
- Diagnosed as bacterial upper respiratory tract infection.
- Patients with onset time more than 72 hours.
- With severe cardiac, hepatic and renal insufficiency(ALT and AST are 1.5 times above the upper limit of normal value), abnormal renal function(Scr abnormality) .
- Treated with antiviral drugs orally within two weeks or for external use within one week before inclusion.
- Participated in other clinical trials and took the study medication within one month before inclusion.
- People with low immune function, systemic failure or long-term use of glucocorticoids and immunosuppressants.
- Those who suffer from nervous and mental diseases and cannot cooperate well.
- Allergy constitution(allergic to more than two kinds of drugs or food)or known allergy to interferon and its matrix.
- Because of other diseases that affect the efficacy observer of this study.
- Other conditions considered by the investigator as not appropriate to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose group
1 bottle of recombinant human interferon ω spray and 1 bottle of placebo(recombinant human interferon ω spray mimics)+base drugs(Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules).
Each bottle of medication is sprayed once, twice a day.
After using the medication, no food or water can be consumed for 20 minutes.
Follow the doctor's instructions for use of the base drugs.
This treatment course can last up to 7 days.
|
8 ml/bottle(contain 2 million IU recombinant human interferon ω)
|
Experimental: High dose group
2 bottle of recombinant human interferon ω spray +base drugs(Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules).
Each bottle of medication is sprayed once, twice a day.
After using the medication, no food or water can be consumed for 20 minutes.
Follow the doctor's instructions for use of the base drugs.
This treatment course can last up to 7 days.
|
8 ml/bottle(contain 2 million IU recombinant human interferon ω)
|
Placebo Comparator: Placebo group
2 bottle of placebo(recombinant human interferon ω spray mimics)+base drugs(Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules).
Each bottle of medication is sprayed once, twice a day.
After using the medication, no food or water can be consumed for 20 minutes.
Follow the doctor's instructions for use of the base drugs.
This treatment course can last up to 7 days.
|
8 ml/bottle(contain 2 million IU recombinant human interferon ω)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete antipyretic time
Time Frame: 0-7 days post each drug use
|
the axillary temperature returns to normal (37.4℃) and remains for 24 h or more.
|
0-7 days post each drug use
|
Incidence of adverse reaction (AR)
Time Frame: 0-14 days post each drug use
|
Incidence of adverse reaction (AR)
|
0-14 days post each drug use
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effective rate of relieving symptoms of upper respiratory tract infection
Time Frame: 0-7 days post each drug use
|
all symptoms of upper respiratory tract infection(nasal congestion, runny nose, sneezing, sore throat, cough)were alleviated efficiently.
Judging the severity of the condition through scoring criteria.
|
0-7 days post each drug use
|
Recovery time
Time Frame: 0-7 days post each drug use
|
the time required for complete fever relief and all symptoms to be relieved
|
0-7 days post each drug use
|
Use rate of antimicrobial drugs and antipyretic drugs
Time Frame: 0-7 days post each drug use
|
Types and frequency of use of antibacterial and antipyretic drugs
|
0-7 days post each drug use
|
Incidence of complications
Time Frame: 0-7 days post each drug use
|
Incidence of complications
|
0-7 days post each drug use
|
Recurrence rate of cured subjects
Time Frame: 0-7 days post each drug use
|
Recurrence rate of cured subjects
|
0-7 days post each drug use
|
Laboratory examination
Time Frame: 0-7 days post each drug use
|
Changes in laboratory indicators,such as red blood cell count; platelet count; glutamic-pyruvic transaminase; urinary protein and so on.
|
0-7 days post each drug use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Zhichuan Feng, M.M, Seventh Medical Center of PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2023
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
May 7, 2023
First Posted (Actual)
May 16, 2023
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 7, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFNω-VI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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