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
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.
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 →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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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:
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:
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:
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.
Placebo Group: Take the Onradivir Tablets matching placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses).
Drug: Placebo
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
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).
Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).
Time to alleviation of influenza symptoms
Time frame: Up to Day 15
Time to fever resolution
axillary temperature ≤37.2°C
Time frame: 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)
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
Area under the curve (AUC) of viral quantification (viral titer and viral RNA load) versus time
Time frame: 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.)
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 to resolution of systemic symptoms (headache, fever or chills, muscle or joint pain, fatigue)
Time frame: Up to Day 15
Time to resolution of respiratory symptoms
Time to resolution of respiratory symptoms (cough, sore throat, nasal congestion)
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
Plan to share: Yes
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