InfluenzaPhase 3NCT07229547
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Onradivir Tablets in Participants Aged 12 to 17 Years With Uncomplicated Influenza A.
A Phase 3 study testing Onradivir tablet in people with Influenza, run by Ruijin Hospital at 1 site in China.
Trial summary
This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Onradivir Tablets in participants aged 12 to 17 years with influenza A virus infection. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Influenza
- What is being tested?
- Onradivir tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2025to 1 Dec 2027
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
- All participants must meet all of the following criteria:
- Aged 12 to 17 years (inclusive), regardless of gender.
- Diagnosed with influenza A based on the following criteria:
- Positive for influenza A virus infection by Rapid Antigen Test (RAT) or nucleic acid testing of nasopharyngeal/oropharyngeal swab at screening.
- Axillary temperature ≥38°C at screening. If this criterion is not met due to antipyretic use, reassessment may be performed >4 hours after the most recent antipyretic administration.
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- Presence of at least one moderate or severe influenza-related systemic symptom (headache, fever or chills, muscle or joint pain, fatigue) at screening.
- Presence of at least one moderate or severe influenza-related respiratory symptom (cough, sore throat, nasal congestion) at screening.
- Onset of the first influenza symptom/sign occurring within ≤48 hours before randomization. Influenza symptoms/signs include fever (based on participant-reported data, body temperature ≥37.5°C), headache, muscle or joint pain, fatigue, cough, sore throat, and nasal congestion.
- Participant's parent/legal guardian and the participant themselves provide signed informed consent before the trial, with full understanding of the trial content, procedures, and potential adverse reactions.
- In the investigator's judgment, the participant and their parent/legal guardian are willing and able to comply with the study protocol requirements.
Who cannot join
- Participants will be excluded from the study if they meet any of the following criteria:
- Judged by the investigator as having severe or critical influenza.
- Having allergic constitution, known allergy to Anladiwei or paracetamol, and/or clinically suspected intolerance, or having contraindications.
- Difficulty swallowing the investigational product, or history of gastrointestinal diseases that severely affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, partial gastrectomy, etc.).
- History of febrile seizures.
- High-risk population for severe cases, defined as having any of the following conditions:
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- Respiratory diseases judged clinically significant by the investigator (e.g., interstitial lung disease, pulmonary hypertension, cystic fibrosis, asthma), metabolic diseases, hematological diseases, cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, neurological and neuromuscular diseases, psychiatric disorders, or other serious underlying conditions.
- Immunocompromised status, such as malignant tumors, organ or bone marrow transplantation, HIV infection, or use of systemic immunosuppressants within the past 3 months.
- Concurrent conditions requiring treatment with medications containing aspirin or salicylates.
- History of allergic diseases requiring regular use of antihistamines or other prohibited medications; or occurrence of acute respiratory infection, bronchitis, otitis media, or sinusitis within 2 weeks before onset (appearance of the first influenza symptom/sign); or presence of respiratory symptoms (cough, nasal congestion, runny nose, sore throat) within 1 week before onset.
- Presence of suspected pharyngoconjunctival fever, herpangina, measles, purulent tonsillitis, or other respiratory infectious diseases or communicable diseases.
- Suspected co-infection requiring systemic treatment, in addition to influenza A virus infection.
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, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Jieming Qu, +86 2164370045-68070, jmqu0906@163.com
About this study
This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Onradivir Tablets in participants aged 12 to 17 years with influenza A virus infection.
The trial plans to enroll approximately 150 adolescent participants (12-17 years) with uncomplicated influenza A, confirmed by rapid antigen/nucleic acid testing and within 48 hours of symptom onset. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized in a 2:1 ratio to receive either Onradivir Tablets or placebo once daily for 5 consecutive days.
Read more
The study consists of a screening period, a treatment period, and a safety follow-up period. Each participant will be followed up until Day 14 after the first dose. Nasopharyngeal swabs will be collected at screening, Day 2, Day 4, Day 5, and Day 10 for virological testing, including:
Viral load measurement by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
Viral titer determination by culture assay (50% tissue culture infectious dose, TCID₅₀)
Throughout the treatment and safety follow-up periods, participants will record body temperature, influenza symptom scores, and daily activity scores using a diary card. Clinical laboratory tests will be performed at screening, Day 5, and Day 15. Physical examinations and vital signs measurements will be conducted at each follow-up visit. Adverse events and concomitant medications will be documented throughout the study.
- Conditions
- Influenza
- Being tested
- Placebo, Onradivir tablet
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
A placebo that resembles Onradivir tablet in appearance, weight, and odor. The external packaging of Onradivir tablet and the placebo is identical. Take placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses).
Onradivir tabletDrug
Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo Group:
Take the Onradivir Tablets matching placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses). Receives: Drug: Placebo |
| Onradivir Tablet Group | Experimental | Onradivir Tablets Group:
Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses). Receives: Drug: Onradivir tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to alleviation of influenza symptoms
Measured: Up to Day 15
Secondary outcomes (13)
Time to fever resolution
axillary temperature ≤37.2°C
Measured: Up to Day 15
Change from baseline in influenza A viral quantification
Change from baseline in influenza A viral quantification (viral titer and viral RNA load)
Measured: Up to Day 15
Duration of detectable viral titer and viral RNA load
Measured: Up to Day 15
Proportion of participants with positive viral titer and viral load
Measured: Up to Day 15
Area under the curve of viral quantification versus time
Area under the curve (AUC) of viral quantification (viral titer and viral RNA load) versus time
Measured: Up to Day 15
Incidence of influenza-related complications
Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, pneumonia, myocarditis, pericarditis, neurological complications, musculoskeletal complications, etc.)
Measured: Up to Day 15
Proportion of participants with symptom resolution
Measured: Up to Day 15
Time to resolution of systemic symptoms
Time to resolution of systemic symptoms (headache, fever or chills, muscle or joint pain, fatigue)
Measured: Up to Day 15
Time to resolution of respiratory symptoms
Time to resolution of respiratory symptoms (cough, sore throat, nasal congestion)
Measured: Up to Day 15
Time to resolution of individual symptoms
Measured: Up to Day 15
Proportion of participants with fever resolution
Measured: Up to Day 15
Proportion and frequency of participants using symptomatic treatment medications
Measured: Up to Day 15
Time to return to normal daily activities
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start14 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229547
- Sponsor's protocol ID
- RuijinH
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Onradivir Tablets in Participants Aged 12 to 17 Years With Uncomplicated Influenza A.
- ClinicalTrials.gov ID
- NCT07229547
- Acronym / sponsor ID
- RuijinH
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Nov 2025 (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 randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Onradivir Tablets in participants aged 12 to 17 years with influenza A virus infection.
The trial plans to enroll approximately 150 adolescent participants (12-17 years) with uncomplicated influenza A, confirmed by rapid antigen/nucleic acid testing and within 48 hours of symptom onset. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized in a 2:1 ratio to receive either Onradivir Tablets or placebo once daily for 5 consecutive days.
The study consists of a screening period, a treatment period, and a safety follow-up period. Each participant will be followed up until Day 14 after the first dose. Nasopharyngeal swabs will be collected at screening, Day 2, Day 4, Day 5, and Day 10 for virological testing, including:
Viral load measurement by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
Viral titer determination by culture assay (50% tissue culture infectious dose, TCID₅₀)
Throughout the treatment and safety follow-up periods, participants will record body temperature, influenza symptom scores, and daily activity scores using a diary card. Clinical laboratory tests will be performed at screening, Day 5, and Day 15. Physical examinations and vital signs measurements will be conducted at each follow-up visit. Adverse events and concomitant medications will be documented throughout the study.
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 |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo Group: Take the Onradivir Tablets matching placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses). |
| Onradivir Tablet Group | Experimental | Drug: Onradivir tabletOnradivir Tablets Group: Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- -
- Aged 12 to 17 years (inclusive), regardless of gender.
- Positive for influenza A virus infection by Rapid Antigen Test (RAT) or nucleic acid testing of nasopharyngeal/oropharyngeal swab at screening.
- Axillary temperature ≥38°C at screening. If this criterion is not met due to antipyretic use, reassessment may be performed >4 hours after the most recent antipyretic administration.
- Presence of at least one moderate or severe influenza-related systemic symptom (headache, fever or chills, muscle or joint pain, fatigue) at screening.
Key exclusion criteria (12 listed)
- Participants will be excluded from the study if they meet any of the following criteria:
- Judged by the investigator as having severe or critical influenza.
- Having allergic constitution, known allergy to Anladiwei or paracetamol, and/or clinically suspected intolerance, or having contraindications.
- Difficulty swallowing the investigational product, or history of gastrointestinal diseases that severely affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, partial gastrectomy, etc.).
- History of febrile seizures.
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 |
|---|---|---|
| PlaceboA placebo that resembles Onradivir tablet in appearance, weight, and odor. The external packaging of Onradivir tablet and the placebo is identical. Take placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses). | Drug | Placebo Group |
| Onradivir tabletTake Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses). | Drug | Onradivir Tablet Group |
Primary outcome
Time to alleviation of influenza symptoms
Time frame: Up to Day 15
13 secondary outcomes
Time to fever resolution
Time frame: Up to Day 15
Change from baseline in influenza A viral quantification
Time frame: Up to Day 15
Duration of detectable viral titer and viral RNA load
Time frame: Up to Day 15
Proportion of participants with positive viral titer and viral load
Time frame: Up to Day 15
Area under the curve of viral quantification versus time
Time frame: Up to Day 15
Incidence of influenza-related complications
Time frame: Up to Day 15
Proportion of participants with symptom resolution
Time frame: Up to Day 15
Time to resolution of systemic symptoms
Time frame: Up to Day 15
Time to resolution of respiratory symptoms
Time frame: Up to Day 15
Time to resolution of individual symptoms
Time frame: Up to Day 15
Proportion of participants with fever resolution
Time frame: Up to Day 15
Proportion and frequency of participants using symptomatic treatment medications
Time frame: Up to Day 15
Time to return to normal daily activities
Time frame: Up to Day 15
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 15 Jul 2026.
- Individual participant dataSharing planned: Yes
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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 Onradivir tablet in people with Influenza, run by Ruijin Hospital 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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 Jieming Qu (+86 2164370045-68070, jmqu0906@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 influenza symptoms (time frame: Up to Day 15). 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 15 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.