Onradivir tablets for adolescents with uncomplicated influenza A

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter Phase III trial is a randomized, double-blind, placebo-controlled study in adolescents aged 12 to 17 with uncomplicated influenza A. Participants are assigned in a 2:1 ratio to receive either Onradivir tablets or placebo once daily for five days, starting within 48 hours of symptom onset. The study includes a screening, treatment, and safety follow-up through Day 14, with virological testing and symptom monitoring at specified visits. The primary aim is to evaluate the safety and efficacy of Onradivir in reducing viral load and alleviating symptoms while monitoring adverse events. The lead sponsor is Ruijin Hospital in Shanghai, with the trial conducted at Ruijin Hospital only.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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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:

* 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:

* 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.

Where it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jieming Qu
• Email: jmqu0906@163.com
• Phone: +86 2164370045-68070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.