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

NCT05859984 | Unknown Phase 2

• 1 other identifier: IFNω-VI
• Study Type: interventional
• Target: 345
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Viral Upper Respiratory Tract Infection

Keywords

Viral Upper Respiratory Tract Infection; recombinant human interferon ω; Safety; Efficacy; 3-12 years

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of adverse reaction (AR)

  Incidence of adverse reaction (AR)

  0-14 days post each drug use

Secondary Outcomes (6)

• The effective rate of relieving symptoms of upper respiratory tract infection

  0-7 days post each drug use

• Recovery time

  0-7 days post each drug use

• Use rate of antimicrobial drugs and antipyretic drugs

  0-7 days post each drug use

• Incidence of complications

  0-7 days post each drug use

• Recurrence rate of cured subjects

  0-7 days post each drug use

Study Arms (3)

Low dose group

EXPERIMENTAL

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.

Drug: recombinant human interferon ω spray

High dose group

EXPERIMENTAL

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.

Drug: recombinant human interferon ω spray

Placebo group

PLACEBO COMPARATOR

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.

Drug: recombinant human interferon ω spray

Interventions

recombinant human interferon ω spray DRUG

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

High dose group; Low dose group; Placebo group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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） .
• 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.

Sponsors & Collaborators

• Seventh Medical Center of PLA General Hospital: lead
• The General Hospital of Central Theater Command: collaborator
• The General Hospital of Northern Theater Command: collaborator

Study Officials

• Zhichuan Feng, M.M

  Seventh Medical Center of PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhichun Feng, M.M

CONTACT

+86(10) 66721786; zhjfengzc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 16, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05