Viral Upper Respiratory Tract InfectionPhase 2NCT05859984
To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children
A Phase 2 study testing recombinant human interferon ω spray in people with Viral Upper Respiratory Tract Infection, run by Seventh Medical Center of PLA General Hospital.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Viral Upper Respiratory Tract Infection
- What is being tested?
- recombinant human interferon ω spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- May 2023to May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- recombinant human interferon ω spray
- Keywords
- Viral Upper Respiratory Tract Infection, recombinant human interferon ω, Safety, Efficacy, 3-12 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human interferon ω sprayDrug
8 ml/bottle（contain 2 million IU recombinant human interferon ω）
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: recombinant human interferon ω spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete antipyretic time
the axillary temperature returns to normal （37.4℃） and remains for 24 h or more.
Measured: 0-7 days post each drug use
Incidence of adverse reaction (AR)
Incidence of adverse reaction (AR)
Measured: 0-14 days post each drug use
Secondary outcomes (6)
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.
Measured: 0-7 days post each drug use
Recovery time
the time required for complete fever relief and all symptoms to be relieved
Measured: 0-7 days post each drug use
Use rate of antimicrobial drugs and antipyretic drugs
Types and frequency of use of antibacterial and antipyretic drugs
Measured: 0-7 days post each drug use
Incidence of complications
Incidence of complications
Measured: 0-7 days post each drug use
Recurrence rate of cured subjects
Recurrence rate of cured subjects
Measured: 0-7 days post each drug use
Laboratory examination
Changes in laboratory indicators，such as red blood cell count; platelet count; glutamic-pyruvic transaminase; urinary protein and so on.
Measured: 0-7 days post each drug use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seventh Medical Center of PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Central Theater Command, The General Hospital of Northern Theater Command
- Responsible party
- Sponsor
- Investigators
- Zhichuan Feng, M.M, Principal investigator, Seventh Medical Center of PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859984
- Sponsor's protocol ID
- IFNω-VI
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05859984
- Acronym / sponsor ID
- IFNω-VI
- Conditions
- Viral Upper Respiratory Tract Infection
- Keywords
- Viral Upper Respiratory Tract Infection, recombinant human interferon ω, Safety, Efficacy, 3-12 years
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Seventh Medical Center of PLA General HospitalUniversity, hospital or other
- Collaborators
- The General Hospital of Central Theater Command, The General Hospital of Northern Theater Command
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: recombinant human interferon ω spray1 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. |
| High dose group | Experimental | Drug: recombinant human interferon ω spray2 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. |
| Placebo group | Placebo comparator | Drug: recombinant human interferon ω spray2 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human interferon ω spray8 ml/bottle（contain 2 million IU recombinant human interferon ω） | Drug | High dose group, Low dose group, Placebo group |
Primary outcome
Complete antipyretic time
Time frame: 0-7 days post each drug use
the axillary temperature returns to normal （37.4℃） and remains for 24 h or more.
Incidence of adverse reaction (AR)
Time frame: 0-14 days post each drug use
Incidence of adverse reaction (AR)
6 secondary outcomes
The effective rate of relieving symptoms of upper respiratory tract infection
Time frame: 0-7 days post each drug use
Recovery time
Time frame: 0-7 days post each drug use
Use rate of antimicrobial drugs and antipyretic drugs
Time frame: 0-7 days post each drug use
Incidence of complications
Time frame: 0-7 days post each drug use
Recurrence rate of cured subjects
Time frame: 0-7 days post each drug use
Laboratory examination
Time frame: 0-7 days post each drug use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhichuan Feng, M.M principal investigator
Seventh Medical Center of PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant human interferon ω spray in people with Viral Upper Respiratory Tract Infection, run by Seventh Medical Center of PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhichun Feng, M.M (+86(10) 66721786, zhjfengzc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete antipyretic time (time frame: 0-7 days post each drug use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.