Influenza InfectionPhase 3NCT07791251
Efficacy and Safety of Inhaled Peramivir Solution for the Treatment of Adults With Uncomplicated Influenza
A Phase 3 study testing Peramivir Inhalation Solution in people with Influenza Infection, run by Capital Medical University at 1 site in China.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study will evaluate the efficacy and safety of peramivir inhalation solution in adults with uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza Infection
- What is being tested?
- Peramivir Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2026to 6 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- The participant or the participant's legally authorized representative understands the study and voluntarily signs the informed consent form. The participant must be 18 to 64 years of age, inclusive, at the time of informed consent.
- At screening, the participant meets all of the following criteria:
- Positive result from a rapid influenza diagnostic test (antigen test) or polymerase chain reaction (PCR) test.
- Axillary temperature of at least 37.3°C at screening. If an antipyretic has been taken, the axillary temperature must be at least 37.3°C at least 4 hours after administration.
- At least one influenza-related systemic symptom of moderate or greater severity: muscle or joint pain, fatigue, headache, or feverishness/chills.
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- At least one influenza-related respiratory symptom of moderate or greater severity: nasal congestion, sore throat, or cough.
- The interval between the onset of the first influenza symptom and initiation of study treatment is no more than 48 hours. Symptom onset is defined as either:
- The first occurrence of a temperature of at least 37.3°C measured axillary, 37.5°C measured orally, or 38.0°C measured rectally or tympanically; or The onset of at least one systemic or respiratory symptom: nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, or feverishness/chills.
- The participant is able to comply with all study procedures and complete the participant diary as required.
- A female participant must meet either of the following criteria:
- Not of childbearing potential, defined as having undergone hysterectomy or bilateral oophorectomy, having medically documented ovarian failure, or being postmenopausal. Postmenopausal status is defined as age greater than 50 years with amenorrhea for at least 12 months; or Of childbearing potential, with a negative pregnancy test at screening, and not pregnant, in the peripartum period, or breastfeeding.
- The participant and the participant's partner agree to remain completely abstinent or use effective contraception from screening through 3 months after completion of study treatment. Acceptable methods include:
- For a female participant or the female partner of a male participant, one of the following methods together with correct condom use by the male partner: an intrauterine device with an annual failure rate of less than 1%, a female barrier method consisting of a cervical cap or diaphragm with spermicide, or tubal sterilization; or Prior vasectomy of the male participant or the male partner of a female participant.
- Male participants agree not to donate sperm from screening through 3 months after completion of study treatment.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Influenza requiring hospitalization, as indicated by any of the following:
- Severe influenza characterized by one or more of the following:
- Persistent fever accompanied by severe cough, purulent sputum, bloody sputum, or chest pain.
- Tachypnea, difficulty breathing, or cyanosis of the lips.
- Altered mental status, including reduced responsiveness, somnolence, or agitation, or the occurrence of seizures.
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- Severe vomiting or diarrhea with evidence of dehydration.
- Pneumonia.
- Marked exacerbation of a pre-existing underlying disease.
- Any other clinical condition requiring hospitalization.
- Critical influenza characterized by one or more of the following:
- Respiratory failure.
- Acute necrotizing encephalopathy.
- Shock.
- Multiple organ dysfunction.
- Any other serious clinical condition requiring intensive monitoring or care.
- High risk of severe influenza, as indicated by any of the following:
- A serious or poorly controlled underlying condition, such as chronic pulmonary disease, liver disease, chronic kidney disease, severe hematologic disease, chronic congestive heart failure classified as New York Heart Association functional class III or IV, neurologic or neuromuscular disease, or metabolic disease.
- Clinically significant QT interval abnormality on electrocardiography, defined as a Fridericia-corrected QT interval (QTcF) greater than 450 milliseconds for males or greater than 470 milliseconds for females.
- Immunodeficiency, including malignancy, organ or bone marrow transplantation, human immunodeficiency virus infection, or use of immunosuppressive therapy within the previous 3 months.
- A concomitant condition requiring treatment with aspirin- or salicylate-containing medication.
- Bronchitis, pneumonia, pleural effusion, or interstitial lung abnormality that is clinically suspected or confirmed by chest imaging (posteroanterior or posteroanterior and lateral chest radiography, or computed tomography) at screening and considered clinically significant by the investigator.
- Previous diagnosis of chronic obstructive pulmonary disease, severe allergic rhinitis, or asthma.
- Acute respiratory tract infection, otitis media, or sinusitis within 2 weeks before screening.
- A concomitant infection requiring systemic anti-infective treatment, or a white blood cell count greater than 10.0 × 10^9/L at screening.
- Purulent sputum or suppurative tonsillitis at screening.
- Suspected hypersensitivity to any active ingredient or excipient of the investigational product or acetaminophen.
- Use of any anti-influenza antiviral medication within 7 days before screening, including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion-channel blockers, or RNA polymerase inhibitors, such as oseltamivir, zanamivir, peramivir, umifenovir (Arbidol), favipiravir, rimantadine, amantadine, baloxavir marboxil, onradivir, suraxavir marboxil, seloxavir marboxil, or pixavir marboxil.
- Receipt of an influenza vaccine within 6 months before screening.
- Suspected or confirmed history of alcohol or drug abuse.
- Participation in another interventional drug or medical device clinical trial within 28 days before screening.
- Positive test for SARS-CoV-2 at screening.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100
Bin Cao, caobin_ben@163.com
About this study
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Inhaled Peramivir Solution for the Treatment of Adults With Uncomplicated Influenza
This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study will evaluate the efficacy and safety of peramivir inhalation solution in adults with uncomplicated influenza. Approximately 600 participants aged 18 to 64 years with laboratory-confirmed influenza and symptom onset within 48 hours will be randomized in a 2:1 ratio to receive a single nebulized dose of peramivir inhalation solution 80 mg or matching placebo.
The primary efficacy outcome is the time to alleviation of all seven influenza symptoms. Secondary outcomes include changes in influenza viral RNA and infectious viral titers, time to viral clearance, alleviation of respiratory and systemic symptoms, resolution of fever, influenza-related complications, and use of rescue medication. Safety will be assessed through adverse events, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms. Pharmacokinetics will also be evaluated in a subset of approximately 90 participants. Participants will be followed for approximately 15 days.
- Conditions
- Influenza Infection
- Being tested
- Peramivir Inhalation Solution, Placebo for Peramivir Inhalation Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peramivir Inhalation SolutionDrug
Participants will receive a single nebulized dose of matching placebo on Day 1. The placebo will be administered as two 2-mL ampules containing no active peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration.
Placebo for Peramivir Inhalation SolutionDrug
Participants will receive a single nebulized administration of matching placebo on Day 1. Two 2-mL placebo ampules containing no active peramivir will be placed in the nebulizer, for a total volume of 4 mL. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration.
| Study group | Role | What they receive |
|---|---|---|
| Peramivir Inhalation Solution | Experimental | Participants will receive a single nebulized dose of peramivir inhalation solution 80 mg on Day 1. The 80-mg dose will be administered as two 2-mL ampules, each containing 40 mg of peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration. Receives: Drug: Peramivir Inhalation Solution |
| Placebo for Peramivir Inhalation Solution | Placebo comparator | Participants will receive a single nebulized dose of matching placebo on Day 1. The placebo will be administered as two 2-mL ampules containing no active peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration. Receives: Drug: Placebo for Peramivir Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Alleviation of All Influenza Symptoms
Time in hours from initiation of study treatment to alleviation of all seven influenza symptoms recorded in the participant diary. The seven symptoms are nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, and feverishness or chills. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all seven symptoms, maintained for at least 21.5 hours.
Measured: From initiation of study treatment through 336 hours after treatment
Secondary outcomes (15)
Change From Baseline in Influenza Virus RNA and Viral Titer
Change from baseline in influenza virus RNA measured by quantitative PCR (qPCR; log10 copies/mL) and influenza viral titer (log10 TCID50/mL) at scheduled visits.
Measured: Baseline (pre-dose), Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.
Weighted Time to Alleviation of Five Core Influenza Symptoms
Weighted time in hours from initiation of study treatment to alleviation of all five core influenza symptoms: feverishness or chills, cough, nasal congestion, sore throat, and headache. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all five symptoms, maintained for at least 21.5 hours. Symptom-specific weights will be applied as prespecified in the statistical analysis plan.
Measured: From initiation of study treatment through 336 hours after treatment
Time to Influenza Viral RNA Negativity
Time in hours from initiation of study treatment to the first respiratory specimen in which influenza viral RNA is below the assay limit of detection, as measured by quantitative polymerase chain reaction.
Measured: From initiation of study treatment through Day 15 (+3 days)
Time to Influenza Virus Titer Negativity
Time in hours from initiation of study treatment to the first respiratory specimen in which the infectious influenza virus titer is below the assay lower limit of quantification.
Measured: From initiation of study treatment through Day 15 (+3 days)
Proportion of Participants With Influenza Virus RNA Below the LOD and Viral Titer Below the LLOQ
Proportion of participants with influenza virus RNA below the qPCR LOD and influenza viral titer below the LLOQ at each scheduled visit.
Measured: Baseline, Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.
Percentage of Participants With Alleviation of All Influenza Symptoms
Percentage of participants with scores of 0 (absent) or 1 (mild) for all seven influenza symptoms, maintained for at least 21.5 hours.
Measured: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Percentage of Participants With Alleviation of All Respiratory Symptoms
Percentage of participants with scores of 0 (absent) or 1 (mild) for all three respiratory symptoms-nasal congestion, sore throat, and cough-maintained for at least 21.5 hours.
Measured: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Time to Alleviation of All Respiratory Symptoms
Time in hours from initiation of study treatment to alleviation of nasal congestion, sore throat, and cough. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all three symptoms, maintained for at least 21.5 hours.
Measured: From initiation of study treatment through 336 hours after treatment
Percentage of Participants With Alleviation of All Systemic Symptoms
Percentage of participants with scores of 0 (absent) or 1 (mild) for all four systemic symptoms-muscle or joint pain, fatigue, headache, and feverishness or chills-maintained for at least 21.5 hours.
Measured: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Time to Alleviation of All Systemic Symptoms
Time in hours from initiation of study treatment to alleviation of muscle or joint pain, fatigue, headache, and feverishness or chills. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all four symptoms, maintained for at least 21.5 hours.
Measured: From initiation of study treatment through 336 hours after treatment
Time to Alleviation of Each Individual Influenza Symptom
Time in hours from initiation of study treatment to alleviation of each of the seven influenza symptoms, assessed separately: nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, and feverishness or chills. Alleviation is defined as a score of 0 (absent) or 1 (mild), maintained for at least 21.5 hours.
Measured: From initiation of study treatment through 336 hours after treatment
Time to Alleviation of Fever
Time in hours from initiation of study treatment to the first axillary temperature below 37.0°C that is maintained for at least 12 hours.
Measured: From initiation of study treatment through 336 hours after treatment
Percentage of Participants With Normalization of Body Temperature
Percentage of participants with an axillary temperature below 37.0°C that is maintained for at least 12 hours.
Measured: At 24, 48, 72, 96, 120, 144, and 168 hours after initiation of study treatment
Percentage of Participants With Influenza-Related Complications
Percentage of participants experiencing one or more influenza-related complications, including hospitalization, death, sinusitis, bronchitis, otitis media, or radiographically confirmed pneumonia.
Measured: From initiation of study treatment through Day 15 (+3 days)
Use of Acetaminophen for Influenza-Related Symptoms
Proportion of participants using acetaminophen and frequency of acetaminophen use during the study treatment period.
Measured: From initiation of study treatment through 336h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start28 Oct 2026 (estimated)
- Primary completion6 Apr 2028 (estimated)
- Study completion6 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791251
- Sponsor's protocol ID
- YW2026-060-01
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Inhaled Peramivir Solution for the Treatment of Adults With Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT07791251
- Acronym / sponsor ID
- YW2026-060-01
- Conditions
- Influenza Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 6 Apr 2028 (estimated)
- Study completion
- 6 May 2028 (estimated)
- First posted
- 27 Aug 2026 (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.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study will evaluate the efficacy and safety of peramivir inhalation solution in adults with uncomplicated influenza. Approximately 600 participants aged 18 to 64 years with laboratory-confirmed influenza and symptom onset within 48 hours will be randomized in a 2:1 ratio to receive a single nebulized dose of peramivir inhalation solution 80 mg or matching placebo.
The primary efficacy outcome is the time to alleviation of all seven influenza symptoms. Secondary outcomes include changes in influenza viral RNA and infectious viral titers, time to viral clearance, alleviation of respiratory and systemic symptoms, resolution of fever, influenza-related complications, and use of rescue medication. Safety will be assessed through adverse events, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms. Pharmacokinetics will also be evaluated in a subset of approximately 90 participants. Participants will be followed for approximately 15 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peramivir Inhalation Solution | Experimental | Drug: Peramivir Inhalation SolutionParticipants will receive a single nebulized dose of peramivir inhalation solution 80 mg on Day 1. The 80-mg dose will be administered as two 2-mL ampules, each containing 40 mg of peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration. |
| Placebo for Peramivir Inhalation Solution | Placebo comparator | Drug: Placebo for Peramivir Inhalation SolutionParticipants will receive a single nebulized dose of matching placebo on Day 1. The placebo will be administered as two 2-mL ampules containing no active peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Participants must meet all of the following criteria:
- The participant or the participant's legally authorized representative understands the study and voluntarily signs the informed consent form. The participant must be 18 to 64 years of age, inclusive, at the time of informed consent.
- Positive result from a rapid influenza diagnostic test (antigen test) or polymerase chain reaction (PCR) test.
- Axillary temperature of at least 37.3°C at screening. If an antipyretic has been taken, the axillary temperature must be at least 37.3°C at least 4 hours after administration.
- At least one influenza-related systemic symptom of moderate or greater severity: muscle or joint pain, fatigue, headache, or feverishness/chills.
Key exclusion criteria (33 listed)
- Participants meeting any of the following criteria will be excluded:
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 |
|---|---|---|
| Peramivir Inhalation SolutionParticipants will receive a single nebulized dose of matching placebo on Day 1. The placebo will be administered as two 2-mL ampules containing no active peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration. | Drug | Peramivir Inhalation Solution |
| Placebo for Peramivir Inhalation SolutionParticipants will receive a single nebulized administration of matching placebo on Day 1. Two 2-mL placebo ampules containing no active peramivir will be placed in the nebulizer, for a total volume of 4 mL. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration. | Drug | Placebo for Peramivir Inhalation Solution |
Primary outcome
Time to Alleviation of All Influenza Symptoms
Time frame: From initiation of study treatment through 336 hours after treatment
Time in hours from initiation of study treatment to alleviation of all seven influenza symptoms recorded in the participant diary. The seven symptoms are nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, and feverishness or chills. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all seven symptoms, maintained for at least 21.5 hours.
15 secondary outcomes
Change From Baseline in Influenza Virus RNA and Viral Titer
Time frame: Baseline (pre-dose), Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.
Weighted Time to Alleviation of Five Core Influenza Symptoms
Time frame: From initiation of study treatment through 336 hours after treatment
Time to Influenza Viral RNA Negativity
Time frame: From initiation of study treatment through Day 15 (+3 days)
Time to Influenza Virus Titer Negativity
Time frame: From initiation of study treatment through Day 15 (+3 days)
Proportion of Participants With Influenza Virus RNA Below the LOD and Viral Titer Below the LLOQ
Time frame: Baseline, Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.
Percentage of Participants With Alleviation of All Influenza Symptoms
Time frame: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Percentage of Participants With Alleviation of All Respiratory Symptoms
Time frame: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Time to Alleviation of All Respiratory Symptoms
Time frame: From initiation of study treatment through 336 hours after treatment
Percentage of Participants With Alleviation of All Systemic Symptoms
Time frame: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Time to Alleviation of All Systemic Symptoms
Time frame: From initiation of study treatment through 336 hours after treatment
Time to Alleviation of Each Individual Influenza Symptom
Time frame: From initiation of study treatment through 336 hours after treatment
Time to Alleviation of Fever
Time frame: From initiation of study treatment through 336 hours after treatment
Percentage of Participants With Normalization of Body Temperature
Time frame: At 24, 48, 72, 96, 120, 144, and 168 hours after initiation of study treatment
Percentage of Participants With Influenza-Related Complications
Time frame: From initiation of study treatment through Day 15 (+3 days)
Use of Acetaminophen for Influenza-Related Symptoms
Time frame: From initiation of study treatment through 336h.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peramivir Inhalation Solution in people with Influenza Infection, run by Capital Medical University at 1 site in China.
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 15 inclusion and 33 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeming Wang, PhD (+86 18810663558, wwyymm_love@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Alleviation of All Influenza Symptoms (time frame: From initiation of study treatment through 336 hours after treatment). 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 31 Aug 2026.