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RecruitingNCT07229547Updated Jul 15, 2026

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 interventional study of Placebo and Onradivir tablet in Influenza, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Ruijin Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 150 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-

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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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:

  • 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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Placebo Group

    Placebo Group: Take the Onradivir Tablets matching placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses).

    Drug: Placebo

  • Experimental
    Onradivir Tablet Group

    Onradivir Tablets Group: Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).

    Drug: Onradivir tablet

Interventions

  • DrugPlacebo

    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).

  • DrugOnradivir tablet

    Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).

06

What researchers measure

Primary outcomes

  1. Time to alleviation of influenza symptoms

    Time frame: Up to Day 15

Secondary outcomes

  1. Time to fever resolution

    axillary temperature ≤37.2°C

    Time frame: Up to Day 15

  2. Change from baseline in influenza A viral quantification

    Change from baseline in influenza A viral quantification (viral titer and viral RNA load)

    Time frame: Up to Day 15

  3. Duration of detectable viral titer and viral RNA load

    Time frame: Up to Day 15

  4. Proportion of participants with positive viral titer and viral load

    Time frame: Up to Day 15

  5. 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

    Time frame: Up to Day 15

  6. Incidence of influenza-related complications

    Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, pneumonia, myocarditis, pericarditis, neurological complications, musculoskeletal complications, etc.)

    Time frame: Up to Day 15

  7. Proportion of participants with symptom resolution

    Time frame: Up to Day 15

  8. Time to resolution of systemic symptoms

    Time to resolution of systemic symptoms (headache, fever or chills, muscle or joint pain, fatigue)

    Time frame: Up to Day 15

  9. Time to resolution of respiratory symptoms

    Time to resolution of respiratory symptoms (cough, sore throat, nasal congestion)

    Time frame: Up to Day 15

  10. Time to resolution of individual symptoms

    Time frame: Up to Day 15

  11. Proportion of participants with fever resolution

    Time frame: Up to Day 15

  12. Proportion and frequency of participants using symptomatic treatment medications

    Time frame: Up to Day 15

  13. Time to return to normal daily activities

    Time frame: Up to Day 15

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital
    Shanghai, Shanghai Municipality 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07229547
Lead sponsor
Ruijin Hospital
Responsible party
Jieming QU (Professor, Ruijin Hospital) — Principal investigator
First posted
Nov 17, 2025
Start date
Nov 14, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jul 15, 2026

Study contacts

Jieming Qu
Contact
jmqu0906@163.com
+86 2164370045-68070

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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