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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: recombinant human interferon ω spray
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.
Drug: recombinant human interferon ω spray
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.
Drug: recombinant human interferon ω spray
8 ml/bottle（contain 2 million IU recombinant human interferon ω）

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seventh Medical Center of PLA General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The General Hospital of Central Theater Command
The General Hospital of Northern Theater Command

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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