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

NCT ID: NCT05859984

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-05-31

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.

Conditions

Viral Upper Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

recombinant human interferon ω spray

Intervention Type: DRUG

8 ml/bottle（contain 2 million IU recombinant human interferon ω）

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.

Group Type: EXPERIMENTAL

recombinant human interferon ω spray

Intervention Type: DRUG

8 ml/bottle（contain 2 million IU recombinant human interferon ω）

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.

Group Type: PLACEBO_COMPARATOR

recombinant human interferon ω spray

Intervention Type: DRUG

8 ml/bottle（contain 2 million IU recombinant human interferon ω）

Interventions

recombinant human interferon ω spray

8 ml/bottle（contain 2 million IU recombinant human interferon ω）

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The General Hospital of Central Theater Command

OTHER

Sponsor Role: collaborator

The General Hospital of Northern Theater Command

OTHER

Sponsor Role: collaborator

Seventh Medical Center of PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhichuan Feng, M.M

Role: PRINCIPAL_INVESTIGATOR

Seventh Medical Center of PLA General Hospital

Central Contacts

Zhichun Feng, M.M

Role: CONTACT

zhjfengzc@126.com

+86(10) 66721786

Other Identifiers

IFNω-VI

Identifier Type: -

Identifier Source: org_study_id