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
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Viral Upper Respiratory Tract Infection
Keywords: Viral Upper Respiratory Tract Infection
recombinant human interferon ω
Safety
Efficacy
3-12 years
Lead sponsor: Seventh Medical Center of PLA General Hospital
Sponsor class: OTHER
Collaborators: name: The General Hospital of Central Theater Command
name: The General Hospital of Northern Theater Command
First posted: 2023-05-16
Enrollment: 345
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete antipyretic time
timeFrame: 0-7 days post each drug use
measure: Incidence of adverse reaction (AR)
timeFrame: 0-14 days post each drug use
Secondary outcomes:
measure: The effective rate of relieving symptoms of upper respiratory tract infection
timeFrame: 0-7 days post each drug use
measure: Recovery time
timeFrame: 0-7 days post each drug use
measure: Use rate of antimicrobial drugs and antipyretic drugs
timeFrame: 0-7 days post each drug use
measure: Incidence of complications
timeFrame: 0-7 days post each drug use
measure: Recurrence rate of cured subjects
timeFrame: 0-7 days post each drug use
measure: Laboratory examination
timeFrame: 0-7 days post each drug use
Other outcomes:
Locations:
Study officials:
affiliation: Seventh Medical Center of PLA General Hospital
name: Zhichuan Feng, M.M
role: PRINCIPAL_INVESTIGATOR
References: