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To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children

Primary Purpose

Viral Upper Respiratory Tract Infection

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
recombinant human interferon ω spray
Sponsored by
Seventh Medical Center of PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Upper Respiratory Tract Infection focused on measuring Viral Upper Respiratory Tract Infection, recombinant human interferon ω, Safety, Efficacy, 3-12 years

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low dose group

    High dose group

    Placebo group

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Complete antipyretic time
    the axillary temperature returns to normal (37.4℃) and remains for 24 h or more.
    Incidence of adverse reaction (AR)
    Incidence of adverse reaction (AR)

    Secondary Outcome Measures

    The effective rate of relieving symptoms of upper respiratory tract infection
    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.
    Recovery time
    the time required for complete fever relief and all symptoms to be relieved
    Use rate of antimicrobial drugs and antipyretic drugs
    Types and frequency of use of antibacterial and antipyretic drugs
    Incidence of complications
    Incidence of complications
    Recurrence rate of cured subjects
    Recurrence rate of cured subjects
    Laboratory examination
    Changes in laboratory indicators,such as red blood cell count; platelet count; glutamic-pyruvic transaminase; urinary protein and so on.

    Full Information

    First Posted
    April 12, 2023
    Last Updated
    May 7, 2023
    Sponsor
    Seventh Medical Center of PLA General Hospital
    Collaborators
    The General Hospital of Central Theater Command, The General Hospital of Northern Theater Command
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05859984
    Brief Title
    To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seventh Medical Center of PLA General Hospital
    Collaborators
    The General Hospital of Central Theater Command, The General Hospital of Northern Theater Command

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Viral Upper Respiratory Tract Infection
    Keywords
    Viral Upper Respiratory Tract Infection, recombinant human interferon ω, Safety, Efficacy, 3-12 years

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    345 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low dose group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    High dose group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    recombinant human interferon ω spray
    Intervention Description
    8 ml/bottle(contain 2 million IU recombinant human interferon ω)
    Primary Outcome Measure Information:
    Title
    Complete antipyretic time
    Description
    the axillary temperature returns to normal (37.4℃) and remains for 24 h or more.
    Time Frame
    0-7 days post each drug use
    Title
    Incidence of adverse reaction (AR)
    Description
    Incidence of adverse reaction (AR)
    Time Frame
    0-14 days post each drug use
    Secondary Outcome Measure Information:
    Title
    The effective rate of relieving symptoms of upper respiratory tract infection
    Description
    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.
    Time Frame
    0-7 days post each drug use
    Title
    Recovery time
    Description
    the time required for complete fever relief and all symptoms to be relieved
    Time Frame
    0-7 days post each drug use
    Title
    Use rate of antimicrobial drugs and antipyretic drugs
    Description
    Types and frequency of use of antibacterial and antipyretic drugs
    Time Frame
    0-7 days post each drug use
    Title
    Incidence of complications
    Description
    Incidence of complications
    Time Frame
    0-7 days post each drug use
    Title
    Recurrence rate of cured subjects
    Description
    Recurrence rate of cured subjects
    Time Frame
    0-7 days post each drug use
    Title
    Laboratory examination
    Description
    Changes in laboratory indicators,such as red blood cell count; platelet count; glutamic-pyruvic transaminase; urinary protein and so on.
    Time Frame
    0-7 days post each drug use

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhichun Feng, M.M
    Phone
    +86(10) 66721786
    Email
    zhjfengzc@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhichuan Feng, M.M
    Organizational Affiliation
    Seventh Medical Center of PLA General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children

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