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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seventh Medical Center of PLA General Hospital
• Collaborators: The General Hospital of Central Theater Command; The General Hospital of Northern Theater Command
• Treatments: Interferons

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.