NCT05859984

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 345 (estimated)
• Sponsor: Seventh Medical Center of PLA General Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	recombinant human interferon ω spray	8 ml/bottle（contain 2 million IU recombinant human interferon ω）

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-05-16
• Last updated: 2023-05-16