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

Viral Upper Respiratory Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05859984
• Other study ID #: IFN?-VI
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Seventh Medical Center of PLA General Hospital
• Contact: Zhichun Feng, M.M
• Phone: +86(10) 66721786
• Email: zhjfengzc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 345
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold
• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Viral Upper Respiratory Tract Infection

Intervention

Drug:
• recombinant human interferon ? spray
8 ml/bottle(contain 2 million IU recombinant human interferon ?)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Seventh Medical Center of PLA General Hospital	The General Hospital of Central Theater Command, The General Hospital of Northern Theater Command

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete antipyretic time	the axillary temperature returns to normal (37.4?) and remains for 24 h or more.	0-7 days post each drug use
Primary	Incidence of adverse reaction (AR)	Incidence of adverse reaction (AR)	0-14 days post each drug use
Secondary	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.	0-7 days post each drug use
Secondary	Recovery time	the time required for complete fever relief and all symptoms to be relieved	0-7 days post each drug use
Secondary	Use rate of antimicrobial drugs and antipyretic drugs	Types and frequency of use of antibacterial and antipyretic drugs	0-7 days post each drug use
Secondary	Incidence of complications	Incidence of complications	0-7 days post each drug use
Secondary	Recurrence rate of cured subjects	Recurrence rate of cured subjects	0-7 days post each drug use
Secondary	Laboratory examination	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